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Medical Technology News | MedTech Dive
MedTech Dive provides medical technology news and analysis for industry professionals. We cover medical devices, diagnostics, digital health, FDA regulation...
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https://www.medtechdive.com/news/JNJ-Abiomed-recall-cybersecurity-heart-pump-controller/802685/
Cybersecurity triggers another recall of J&J’s Impella heart pump controller | MedTech Dive
While no patients have been harmed, the FDA categorized the action as a Class I recall because of the potential for serious injury or death.
medtech divecybersecuritytriggersanotherrecall
https://www.medtechdive.com/news/cardinal-health-recalls-procedure-packs-plastic-syringes-made-china/719577/
Cardinal Health recalls procedure kits over plastic syringes made in China | MedTech Dive
Cardinal listed more than 500 catalog numbers in its recall notice and told customers to remove and discard the syringes.
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https://www.medtechdive.com/news/jj-lands-ce-mark-for-surgical-stapler-that-works-with-ottava-robot/818397/
J&J lands CE mark for surgical stapler that works with Ottava robot | MedTech Dive
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https://www.medtechdive.com/news/digital-health-funding-q1-2022-decrease/622106/
Digital health funding dropped in Q1 to lowest level since 2020: CB Insights | MedTech Dive
The report is directionally in line with the findings of an earlier report from Rock Health, which described how the drying up of deals in February and March...
digital healthcb insightsmedtech divefundingdropped
https://www.medtechdive.com/news/oura-cmo-wearables-fda-pathway/808793/
Ōura’s Ricky Bloomfield proposes new regulatory pathway for wearable health features | MedTech Dive
The chief medical officer is interested in an easier path to market for health screening features in wearable devices.
health featuresmedtech diverickybloomfieldnew
https://www.medtechdive.com/news/advita-ortho-receives-warning-letter-related-to-shoulder-system/814552/
Advita Ortho receives warning letter related to shoulder system | MedTech Dive
Advita Ortho was formed after orthopedic implant maker Exactech sold its assets in bankruptcy.
warning lettermedtech diveorthoreceivesrelated
https://www.medtechdive.com/news/tandem-recalls-mobi-insulin-pumps-over-software-malfunction/818260/
Tandem recalls Mobi insulin pumps over software malfunction | MedTech Dive
A malfunction may cause insulin delivery to stop. Tandem instructed users to update their pump software as soon as possible.
insulin pumpsmedtech divetandemrecallsmobi
https://www.medtechdive.com/news/roche-set-to-launch-rival-to-abbotts-rapid-covid-19-antigen-test/584556/
Roche set to launch rival to Abbott's rapid COVID-19 antigen test | MedTech Dive
The diagnostics giant expects to make 40 million of the instrument-free tests a month when it launches in late September and more than double that by the end...
covid 19medtech diverochesetlaunch
https://www.medtechdive.com/news/medtronics-heartware-receives-another-class-i-recall-after-more-patient-de/595934/
Medtronic's HeartWare receives another Class I recall after more patient deaths | MedTech Dive
The medical device giant is recalling 157 HVAD Pump Implant Kits from the U.S. after receiving complaints that some devices failed to start or restart promptly.
class imedtech divemedtronicreceivesanother
https://www.medtechdive.com/news/zimmer-launches-2-devices-paragon-28/802559/
Zimmer launches 2 devices from $1.1B orthopedic takeover | MedTech Dive
After acquiring Paragon 28 earlier this year, Zimmer intends to maintain the foot and ankle specialist’s double-digit growth.
2 devicesmedtech divezimmerlaunches1b
https://www.medtechdive.com/news/medtronic-leads-100m-investment-in-pulnovo-medical/818033/
Medtronic leads $100M investment in Pulnovo Medical | MedTech Dive
Medtronic formed a commercial agreement with Pulnovo alongside its investment.
medtech divemedtronicleads100minvestment
https://www.medtechdive.com/news/thermo-fisher-completes-89b-buyout-of-clario/815638/
Thermo Fisher completes $8.9B buyout of Clario | MedTech Dive
Thermo Fisher plans to create a fast-growing business by integrating Clario’s data capture and management system with its existing capabilities.
medtech divethermofishercompletesbuyout
https://www.medtechdive.com/news/transenterix-slumps-after-selling-1-robotic-system-in-q1/554521/
TransEnterix slumps after selling 1 robotic system in Q1 | MedTech Dive
TransEnterix expects to sell more systems in the second quarter but investors reacted badly to the results, wiping 29% off the company's stock price.
medtech divesellingroboticsystemq1
https://www.medtechdive.com/news/abbott-posts-q4-sales-below-expectations/810254/
Abbott posts Q4 sales below expectations | MedTech Dive
Pricing challenges in Abbott’s nutrition business and lower than expected sales of continuous glucose monitors drove down the company’s shares.
medtech diveabbottpostsq4sales
https://www.medtechdive.com/news/cms-fda-unveil-speedier-medicare-coverage-pathway-for-breakthrough-devices/818324/
CMS, FDA unveil speedier Medicare coverage pathway for breakthrough devices | MedTech Dive
The pathway is designed to reduce the delay between FDA authorization and Medicare coverage for certain Class II and Class III breakthrough medical devices.
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MedTech industry news
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https://www.medtechdive.com/news/labcorp-closes-acquisition-new-york-pathology-reference-lab-assets/815384/
Labcorp closes purchase of New York pathology reference lab assets | MedTech Dive
The deal, which will see Labcorp run 12 patient service centers, is part of the company’s ongoing efforts to expand through acquisitions.
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https://www.medtechdive.com/news/siemens-healthineers-hologram-app-apple-vision-pro/709703/
Siemens Healthineers launches anatomy hologram app on Apple Vision Pro | MedTech Dive
The prototype app has potential uses in patient communication, medical education and surgical planning.
apple vision prosiemens healthineersmedtech divelaunchesanatomy
https://www.medtechdive.com/news/medtronic-minimed-ipo/808465/
Medtronic’s diabetes spinoff MiniMed files for IPO | MedTech Dive
MiniMed is pitching the breadth of its portfolio as an advantage over more focused rivals such as Dexcom and Insulet.
medtech divediabetesspinofffilesipo
https://www.medtechdive.com/news/fda-approves-pediatric-spine-device-via-humanitarian-pathway/561828/
FDA approves pediatric spine device via humanitarian pathway | MedTech Dive
The device is a less invasive alternative to spinal fusion for adolescents with idiopathic scoliosis.
medtech divefdapediatricspinedevice
https://www.medtechdive.com/news/intuitive-surgical-hit-by-cybersecurity-phishing-incident/814733/
Intuitive Surgical hit by phishing incident | MedTech Dive
The surgical robotics firm said an unauthorized third party accessed customer business and contact information, as well as employee and corporate data.
medtech diveintuitivesurgicalhitphishing
https://www.medtechdive.com/news/move-to-digital-mammography-failed-to-improve-outcomes-study-finds/580508/
Move to digital mammography failed to improve outcomes, study finds | MedTech Dive
A new meta-analysis shows the use of digital versus film mammograms had no effect on likelihood of a tumor being detected between screening scans, despite...
digital mammographyimprove outcomesmedtech divemovefailed
https://www.medtechdive.com/topic/digital-health/
Digital Health | MedTech Dive
The latest news in digital health for professionals in the medtech industry.
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https://www.medtechdive.com/news/ge-healthcare-software-afib-atrial-fibrillation-gehc/691839/
GE HealthCare rolls out software to speed assessment of AFib patients | MedTech Dive
The program aims to cut the time physicians spend searching multiple systems to understand the cardiac history of AFib patients.
ge healthcaremedtech diverollssoftwarespeed
https://www.medtechdive.com/news/minimed-posts-double-digit-sales-growth-widening-net-loss/818078/
MiniMed posts double-digit sales growth, widening net loss | MedTech Dive
New glucose sensors and a partnership with Abbott are expected to drive sales growth at MiniMed, BTIG analyst Marie Thibault wrote.
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About Us | MedTech Dive
MedTech Dive provides medical technology news and analysis for industry professionals. We cover medical devices, diagnostics, digital health, FDA regulation...
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https://www.medtechdive.com/news/Intuitive-Q4-general-surgery-acute-care-da-Vinci-robot-2026-outlook/809847/
Intuitive says general surgery, acute care fuel US robot momentum | MedTech Dive
CEO Dave Rosa said a strong rollout for the da Vinci 5 surgical robot in 2025 exceeded expectations, with the system driving greater utilization than the...
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Whitepapers, webinars, videos | MedTech Dive
Whitepapers, webinars, videos, PDF downloads and other resources about the medtech industry.
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https://www.medtechdive.com/news/shoulder-device-sales-power-wright-to-beat-and-raise-q3/541726/
Shoulder device sales power Wright to beat-and-raise Q3 | MedTech Dive
Strong growth emboldened the company to raise its outlook for the second successive quarter. Jefferies analysts wrote there is "no reason we can see to suggest...
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https://www.medtechdive.com/news/oura-raises-900m-smart-ring/803105/
Ōura raises $900M to develop new health features | MedTech Dive
The investment values the smart-ring maker at $11 billion.
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Diabetes News | MedTech Dive
The latest news and updates on diabetes medical devices for medtech industry professionals.
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https://www.medtechdive.com/news/CGM-AI-diabetes-prevention/638050/
AI detects prediabetes in CGM data, opening up new use for device: study | MedTech Dive
By correctly identifying many patients with prediabetes or Type 2 diabetes, researchers say CGMs can be used to prevent the disease.
opening upmedtech diveaiprediabetescgm
https://www.medtechdive.com/news/cepheid-fda-nod-fingerstick-hepatitis-c-test/720135/
Cepheid wins FDA nod for fingerstick hepatitis C test | MedTech Dive
Patients could be diagnosed and potentially receive treatment at the same healthcare visit.
hepatitis cmedtech divewinsfdanod
https://www.medtechdive.com/news/hospital-staff-shortages-decline-procedures-tavr-procedures/634116/
Hospital staff shortages spurred drop in TAVR procedures in Q3, surgeon survey shows | MedTech Dive
Staffing at hospitals is expected to remain disrupted until at least 2024, reducing the number of surgeries, more than 40% of respondents said.
hospital staffdrop inmedtech diveshortagestavr
https://www.medtechdive.com/news/abbott-gets-ce-mark-for-molecular-diagnostics-machine/550885/
Abbott gets CE mark for molecular diagnostics machine | MedTech Dive
The device expands the company's fast-selling portfolio of Alinity laboratory testing instruments.
ce markmolecular diagnosticsmedtech diveabbottgets
https://www.medtechdive.com/news/zimmer-partners-revelai-generative-ai-orthopedics/718825/
Zimmer, RevelAi partner to sell AI tool for orthopedic care | MedTech Dive
Jun 14, 2024 - RevelAi uses generative artificial intelligence to automate clinical workflows and support patients with conditions such as osteoarthritis.
ai toolorthopedic caremedtech divezimmerpartner
https://www.medtechdive.com/news/medtronics-minimed-goes-public-for-560m/814100/
Medtronic’s MiniMed goes public for $560M | MedTech Dive
The diabetes tech business is now operating as a standalone, public company. Shares began trading on Friday.
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https://www.medtechdive.com/news/illumina-buys-fluent-biosciences-single-cell-technology/720933/
Illumina buys Fluent Biosciences, adding single-cell analysis tech | MedTech Dive
Fluent’s kits compete with products from companies including 10x Genomics, an Illumina partner.
medtech diveilluminafluentbiosciencesadding
https://www.medtechdive.com/news/fda-breakthrough-device-designations-fall-q3/635301/
FDA breakthrough device designations fall in Q3 but record year still within reach | MedTech Dive
If activity accelerates after the summer months, the agency will post another record year for designations.
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https://www.medtechdive.com/news/notified-bodies-EU-proposed-artificial-intelligence-ai-regulation/608880/
Notified bodies join chorus of criticism of proposed European AI regs | MedTech Dive
Team-NB has come out strongly against the regulation, arguing it will add to administrative burdens, reduce notified body capacity and create confusion.
notified bodiesmedtech divejoinchoruscriticism
https://www.medtechdive.com/news/md-anderson-taps-hitachi-for-159m-proton-therapy-expansion/560580/
MD Anderson taps Hitachi for $159M proton therapy expansion | MedTech Dive
The cancer center will more than double the size of its existing site to meet rising demand amid mixed messages about the viability of running proton therapy...
proton therapymedtech divemdandersontaps
https://www.medtechdive.com/news/with-ultrasound-on-a-chip-butterfly-network-aims-for-global-reach/818119/
With ultrasound on a chip, Butterfly Network aims for global reach | MedTech Dive
Butterfly, which makes handheld imaging machines, hopes to make the technology accessible to more patients with its pricing and AI features.
on aglobal reachmedtech diveultrasoundchip
https://www.medtechdive.com/news/resmed-posts-double-digit-growth-as-software-sales-soar/540673/
ResMed posts double-digit growth as software sales soar | MedTech Dive
Results were burnished by the acquisition of home health software provider HEALTHCAREfirst.
software salesmedtech diveresmedpostsdouble
https://www.medtechdive.com/news/robert-f-kennedy-jr-rfk-jr-defends-hhs-tenure-proposed-budget-cut/818052/
RFK Jr. defends HHS tenure, 12% proposed budget cut | MedTech Dive
Republicans largely praised the HHS secretary’s track record during a marathon of House hearings last week, but some GOP lawmakers raised concerns about...
rfk jrproposed budgetmedtech divehhstenure
https://www.medtechdive.com/news/cdrh-director-tarver-previews-ai-guidance-at-aami-event/818213/
CDRH Director Tarver previews AI guidance at AAMI event | MedTech Dive
Michelle Tarver said the device center plans to finalize guidance on AI lifecycle management and provide some initial thoughts on generative AI following an...
ai guidancemedtech divedirectorpreviewsaami
https://www.medtechdive.com/news/diagnostic-deal-volumes-jumped-2021-kpmg/618926/
Diagnostics M&A expected to be strong in 2022 after dealmaking took off last year | MedTech Dive
Respondents to KPMG's survey predict that deal volumes and values for the diagnostics space will jump again this year as companies are ready to spend more of...
m ato bein 2022last yearmedtech dive
https://www.medtechdive.com/news/edwards-raises-2026-forecast-as-tavr-sales-surge/818394/
Edwards raises 2026 forecast as TAVR sales surge | MedTech Dive
The stronger outlook follows mixed results from other major medical device makers in the latest quarter, after both Abbott and Boston Scientific cut their...
medtech diveedwardsforecasttavrsales
https://www.medtechdive.com/topic/recalls/
Medical Device Recalls News | MedTech Dive
The latest news and updates on medtech and medical device recalls
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https://www.medtechdive.com/news/boston-scientific-axios-stent-recall/809947/
Boston Scientific recalls stent over issue linked to 3 deaths | MedTech Dive
The company said the deaths were associated with off-label or investigational use of the device.
boston scientificmedtech diverecallsissuelinked
https://www.medtechdive.com/news/medtronic-buys-nanovis-nano-spine-implants/740027/
Medtronic buys Nanovis’ nano technology for use in spine implants | MedTech Dive
Medtronic will use the technology to develop PEEK interbody spine fusion devices that enhance implant fixation.
nano technologymedtech divemedtronicusespine
https://www.medtechdive.com/news/mhra-approved-bodies-uk-device-certification/692412/
UK regulators name 3 approved bodies to ease device certification bottleneck | MedTech Dive
A MHRA leader hailed the action as “almost doubling capacity for medical device assessment in the U.K.”
device certificationmedtech diveukregulatorsname
https://www.medtechdive.com/news/device-to-id-obstructions-in-post-pci-patients-wins-breakthrough-status/565734/
Device to ID obstructions in post-PCI patients wins breakthrough status | MedTech Dive
Swiss startup CorFlow Therapeutics created the device to both assess and treat microvascular obstruction in patients after percutaneous coronary intervention.
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https://www.medtechdive.com/news/4-studies-to-know-from-hrs-2026/818561/
4 studies to know from HRS 2026 | MedTech Dive
Boston Scientific, Abbott and Medtronic shared new cardiac device data at the annual Heart Rhythm Society meeting, where market share shifts in pulsed field...
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https://www.medtechdive.com/news/boston-scientific-acquire-penumbra/809734/
Boston Scientific to acquire Penumbra for $14.5B | MedTech Dive
With the planned purchase, Boston Scientific will gain several thrombectomy devices to remove clots from blood vessels.
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https://www.medtechdive.com/news/Olympus-buys-Veran-for-300M/591708/
Olympus to pay $300M to buy Veran for lung navigation system | MedTech Dive
The deal is for $300 million up front, with another $40 million tied to an undisclosed milestone.
medtech diveolympuspaybuylung
https://www.medtechdive.com/news/FDA-finalizes-combination-product-guidance/693498/
FDA finalizes combination product guidance 7 years after sharing draft | MedTech Dive
AdvaMed called overlapping human factor requirements of the draft guidance “overly burdensome.”
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https://www.medtechdive.com/news/smiths-medical-recall-syringe-pumps/707606/
Smiths Medical recalls syringe pumps for software malfunction | MedTech Dive
The FDA categorized the recall as Class I, noting that the software faults may cause pumps to fail, delaying or interrupting therapy.
medtech divemedicalrecallssyringepumps
https://www.medtechdive.com/news/medtronic-closes-585m-purchase-of-cathworks/817957/
Medtronic closes $585M purchase of CathWorks | MedTech Dive
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https://www.medtechdive.com/news/jj-to-acquire-atraverse-medical/818514/
J&J to acquire Atraverse Medical | MedTech Dive
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https://www.medtechdive.com/news/medtronic-trial-of-hugo-robot-in-hernia-repair-hits-primary-endpoints/759356/
Medtronic trial of Hugo robot in hernia repair hits primary endpoints | MedTech Dive
The company reported a 100% surgical success rate, beating the pre-specified 85% performance goal to meet the trial’s primary effectiveness endpoint.
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https://www.medtechdive.com/news/perkinelmer-tops-fda-covid-19-test-sensitivity-list-with-bd-and-roche-scor/585480/
PerkinElmer tops FDA COVID-19 test sensitivity list, with BD and Roche scoring lower | MedTech Dive
PerkinElmer’s coronavirus nucleic acid kit achieved the lowest limit of detection, indicating greater sensitivity or ability to accurately detect the virus, in...
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https://www.medtechdive.com/news/Laborie-465M-deal-buy-Jada-post-childbirth-device-Organon/805097/
Laborie inks $465M deal to buy post-childbirth device from Organon | MedTech Dive
Organon tripled sales of the bleeding-control system from 2022 to 2024 and is on track to grow sales again this year.
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https://www.medtechdive.com/news/boston-scientific-slashes-2026-guidance/818196/
Boston Scientific slashes 2026 guidance | MedTech Dive
CEO Mike Mahoney told investors that the lowered forecast reflects challenges for several businesses, including electrophysiology and Watchman.
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https://www.medtechdive.com/news/fda-breakthrough-device-final-guidance-health-equity/693781/
FDA finalizes breakthrough device changes to target health inequities | MedTech Dive
The proposals received positive feedback from groups including AdvaMed, leading the FDA to finalize the changes with only minor revisions.
medtech divefdabreakthroughdevicechanges
https://www.medtechdive.com/news/boston-scientific-dexcom-edwards-medtech-earnings/713936/
Boston Scientific, Dexcom and Edwards next as earnings season rolls on | MedTech Dive
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https://www.medtechdive.com/news/medtronic-reports-data-breach-on-corporate-it-systems/818580/
Medtronic reports data breach on corporate IT systems | MedTech Dive
The medtech company does not expect any material impact on its business or financial results, according to a filing with the Securities and Exchange Commission.
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https://www.medtechdive.com/news/healthcare-technology-outlook-predictions-2025/737558/
Top healthcare technology trends in 2025 | MedTech Dive
How the incoming Trump administration will regulate AI this year remains unclear. Meanwhile, experts say healthcare companies will continue bolstering cyber...
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https://www.medtechdive.com/news/medline-recalls-angiographic-syringes-receives-fda-warning-letter/817433/
Medline recalls angiographic syringes, receives FDA warning letter | MedTech Dive
The company removed the devices from the market in February following complaints of the syringes disconnecting from manifolds.
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https://www.medtechdive.com/news/oss-vr-apple-vision-pro-surgery-training/713030/
Osso VR brings surgery training app to Apple Vision Pro | MedTech Dive
Users can virtually walk through the steps of two orthopedic procedures: total knee replacement and carpal tunnel release.
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https://www.medtechdive.com/news/stryker-begins-restoring-ordering-shipping-systems-after-cyberattack/814982/
Stryker begins restoring ordering, shipping systems after cyberattack | MedTech Dive
The medtech company believes the cyberattack has been contained and is now bringing systems back online.
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https://www.medtechdive.com/news/apple-fends-off-masimo-challenge-to-apple-watch-redesign/818158/
Apple fends off Masimo challenge to Apple Watch redesign | MedTech Dive
Apple can continue selling redesigned Apple Watches with a blood oxygen feature after the International Trade Commission concluded the products do not infringe...
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https://www.medtechdive.com/news/intuitive-surgical-lifts-2026-outlook-for-da-vinci-robot-procedure-growth/818193/
Intuitive Surgical lifts 2026 outlook for da Vinci robot procedure growth | MedTech Dive
The company, whose shares climbed nearly 8% Wednesday morning, also said a recent cyber incident has been contained and did not significantly affect...
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https://www.medtechdive.com/news/eu-proposal-simplify-mdr/808398/
EU proposal would simplify Medical Device Regulation | MedTech Dive
If finalized, the changes would reduce the scope of AI regulations for medical devices and include more provisions for rare disease treatments.
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Medical Device News | MedTech Dive
The latest news and updates on medical devices.
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https://www.medtechdive.com/news/dexcom-cgm-adoption-booms-as-it-looks-to-aggressively-pursue-type-2-marke/559966/
Dexcom CGM adoption booms as it looks to 'aggressively' pursue Type 2 market | MedTech Dive
Coming off another beat-and-raise quarter, the company remains focused on adding users via the pharmacy benefit channel, Medicare population and international...
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https://www.medtechdive.com/news/pulse-biosciences-hires-liane-teplitsky-as-coo/817166/
Pulse Biosciences hires Liane Teplitsky as COO | MedTech Dive
The appointment gives a former Abbott leader oversight of efforts to bring a pulsed field ablation device to market.
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https://www.medtechdive.com/news/fda-starts-510k-pilot-to-cut-optical-tomography-processing-times/540445/
FDA starts 510(k) pilot to cut optical tomography processing times | MedTech Dive
The program aims to give developers of optical coherence tomography devices the chance to discuss premarket performance testing recommendations with the agency.
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https://www.medtechdive.com/news/grail-files-for-fda-approval-of-multi-cancer-early-detection-test/811064/
Grail files for FDA approval of multi-cancer early detection test | MedTech Dive
Premarket approval could help the company secure coverage from commercial payers and Medicare.
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https://www.medtechdive.com/news/advamed-medtech-conference-ai-takeaways/802793/
5 AI takeaways from AdvaMed’s conference | MedTech Dive
Medical device firms discussed privacy, regulations and prioritizing projects as AI becomes more prevalent in the industry.
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https://www.medtechdive.com/news/mcit-breakthrough-pathway-cures-2-legislation/610174/
MCIT breakthrough device payment pathway included in Cures 2.0 bill | MedTech Dive
Lawmakers on Tuesday introduced a revised MCIT proposal in the next version of the 21st Century Cures Act, following last week's repeal of the final rule by...
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https://www.medtechdive.com/news/medtech-earnings-preview-Q1-2022/621945/
Abbott, Intuitive and J&J start medtech earnings season against a turbulent backdrop | MedTech Dive
The results will shed light on whether elective surgery recovery is enough to offset a range of headwinds, such as shortages of key components and rising...
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https://www.medtechdive.com/news/jj-abbott-intuitive-medtech-earnings-q2/721427/
J&J, Abbott and Intuitive start medtech earnings season | MedTech Dive
The companies’ financial results will offer a glimpse at the current health of medtech markets.
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