Medtech sounds alarm on semiconductor shortages, asks feds to prioritize chips for medical use

AdvaMed and several device companies, including BD, Medtronic and Philips, have reiterated to the Biden administration how supply chain constraints are causing an "unsustainable" disruption to the industry.

By Nick Paul Taylor • Nov. 10, 2021

CMS repeals MCIT breakthrough device final rule, leaves open other coverage pathways

The agency on Friday officially rescinded the Medicare Coverage for Innovative Technologies rule due to safety concerns following strong opposition from some healthcare groups, despite strong support for the rule in the medtech industry.

By Nick Paul Taylor • Updated Nov. 12, 2021

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Medical device industry continues to turn to AI

While the industry continues to embrace artificial intelligence, there are still questions about how the new technologies need to be regulated and if they are effective.

By MedTech Dive staff

Philips grows cardiac monitoring business with Cardiologs pickup

Nearly one year after announcing its $2.8 billion acquisition of BioTelemetry, the Dutch conglomerate is further expanding its reach in remote patient monitoring with the purchase of France-based Cardiologs.

By Susan Kelly • Nov. 9, 2021

FDA issues long-awaited draft software guidance in overhaul of 16-year-old policy

The proposal applies to all types of premarket submissions and includes both software in and Software as a Medical Device.

By Nick Paul Taylor • Nov. 4, 2021

Why are women more likely to use telehealth?

As Washington mulls over telehealth regulations post-COVID-19, it's important not to roll back access in a way that could disproportionately affect women, experts say.

By Rebecca Pifer • Nov. 3, 2021

Siemens' Varian leads latest FDA breakthrough device designations

Varian secured the regulatory privileges for its noninvasive treatment of knee osteoarthritis based on technology acquired from Boston Scientific. Magnus Medical, Renovia and MY01 are included in the latest batch of designations.

By Nick Paul Taylor • Nov. 1, 2021

FDA, global peers create guiding principles for AI/ML medical devices

The U.S., U.K. and Canada are seeking international harmonization as part of a broader discussion on the development of safe, effective devices that use artificial intelligence and machine learning.

By Nick Paul Taylor • Oct. 29, 2021

What does J&J's Ottava delay mean for Intuitive and Medtronic? It's complicated.

The setback doesn't remove hurdles the rivals face playing catch-up to market leader Intuitive's da Vinci, which has a two-decade head start. 

By Ricky Zipp • Oct. 28, 2021

FDA's 2022 A-list guidance plan hits on software, post-pandemic future

The agency's priorities include a much-anticipated final guidance on clinical decision support software — more than five years in the making — meant to clarify when CDS meets the definition of a medical device.

By Nick Paul Taylor • Oct. 27, 2021

Like 'Whac-A-Mole': GE Healthcare says supply chain woes to last into 2022

"I'm not sure we're yet in a place where we would say that things are stable," GE CEO Larry Culp told investors Tuesday. The healthcare unit took the biggest hit among the conglomerate's business lines due to delays.

By Greg Slabodkin • Oct. 26, 2021

Notified bodies join chorus of criticism of proposed European AI regs

Team-NB has come out strongly against the regulation, arguing it will add to administrative burdens, reduce notified body capacity and create confusion.

By Nick Paul Taylor • Oct. 26, 2021

Cigna expands telehealth benefits for employer-covered lives, including new virtual-first plan

The virtual-first plans will initially be available to large, self-insured employers, though the insurer is looking to expand to smaller and fully insured clients.

By Rebecca Pifer • Oct. 26, 2021

Amazon teases 5 more cities to get virtual Amazon Care offering this year

Amazon Care is currently live in the Washington, D.C. and Baltimore area, and will be rolled out in Dallas, Chicago, Philadelphia, Boston and Los Angeles this year, the unit's director told the HLTH conference this week.

By Rebecca Pifer • Oct. 22, 2021

Medtronic surgical robotics head talks Hugo, taking on Intuitive, COVID-19 challenges

Megan Rosengarten spoke to MedTech Dive about challenging Intuitive Surgical's 20-year lead in soft tissue robotics, growing global robotics usage and the stress of entering a new market amid COVID-19.

By Ricky Zipp • Oct. 20, 2021

In last ditch plea to save MCIT, medtech groups suggest fixes to CMS

AdvaMed and MDMA responded to a call for feedback on the planned repeal of the Medicare Coverage of Innovative Technology pathway by proposing tweaks and new ideas to salvage it.

By Nick Paul Taylor • Oct. 20, 2021

Medtechs need strategy to prevent bias in AI-machine learning-based devices: FDA

The agency is mulling the types of information medtechs might include in labeling for such devices to support transparency. A Philips rep cautioned about the pitfalls of "information overload."

By Greg Slabodkin • Oct. 15, 2021

Biden circling former FDA chief Califf to again lead agency: report

The Washington Post reported the administration was "closing in" on the choice, citing unnamed sources. Still, the White House declined to comment and Califf could face opposition from Senate Democrats.

By Ricky Zipp • Oct. 15, 2021

Medtronic pledges R&D boost, brand refresh, amid rising Big Tech rivalry

CEO Geoff Martha said the device giant is still "building out that direct-to-consumer muscle" and acknowledged "healthy competition" with the likes of Apple and Google.

By Greg Slabodkin • Oct. 14, 2021

Withings gets FDA nod for AFib-detecting wearable, taking on Apple

The device, which is capable of detecting atrial fibrillation, combines an analog watch face with health features found in digital smartwatches. The French company joins Apple, Fitbit and Samsung in a crowded market.

By Nick Paul Taylor • Oct. 13, 2021

Best Buy's latest health acquisition builds on plan to expand at-home care

The consumer electronics giant is buying UK-based Current Health, whose platform combines remote monitoring, telehealth and data from wearables, as well as algorithms to identify when a patient needs clinical attention.  

By Rebecca Pifer • Oct. 12, 2021

4 takeaways from a bumper year of M&A medtech activity (so far)

After hunkering down last year, many companies entered 2021 with large cash reserves and acquisition targets that included players lacking scale to weather the downturn.

By Nick Paul Taylor • Oct. 11, 2021

Medtechs opened 2021 with a flurry of M&A and have not stopped spending since

With deals ranging from tuck-ins to multibillion-dollar takeovers, here's a roundup of the M&A spree so far this year after activity came to a near halt amid the unpredictability of 2020.

Oct. 7, 2021

Digital health funding shatters record again with $21.3B so far this year

This year, mental health is the top funded clinical indication with $3.1 billion raised, followed by digital health tools for managing cardiovascular disease, diabetes, primary care and oncology.

By Hailey Mensik • Oct. 5, 2021

FDA's real-world evidence push hampered by data challenges, 'million-dollar question'

While the agency wants to tap information like electronic health records and wearables to make pre- and postmarket decisions, these sources do not have the same quality controls as clinical trials. 

By Greg Slabodkin • Oct. 4, 2021

FDA hits nearly all MDUFA IV commitments despite pandemic disruptions

The main black mark in an audit was the failure to publish draft guidance on content for premarket submissions for software in a medical device.

By Nick Paul Taylor • Oct. 4, 2021