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

Over-the-counter hearing aids proposed by FDA

A Cowen analyst said the policy change would allow consumer electronics manufacturers to get into the lucrative hearing aid market that has been dominated by ReSound, Sonova and William Demant. 

By Greg Slabodkin • Oct. 19, 2021

Explore the Trendline➔

Medical device safety in spotlight after high profile recalls

From Philips’ massive recall of respiratory devices to ongoing health risks with breast implants, medical devices tied to patient harm have put a focus on product safety.

By MedTech Dive staff

J&J delays Ottava robot rollout as global medtech business boosts Q3 sales

The healthcare giant was the first procedure-dependent medtech to announce earnings this quarter, potentially foreshadowing what others in the industry will report in the coming weeks.

By Ricky Zipp • Oct. 19, 2021

Philips sees sleep business recovering from recall in H2 2022, analysts doubtful

William Blair analysts warn that limited provider support during the medtech's recall is hurting brand credibility and impacting Philips' ability to regain market share, while positioning ResMed as the beneficiary of "durable" share loss. 

By Greg Slabodkin • Updated Oct. 22, 2021

Medtronic misses bid for early FDA OK in renal denervation, stock slides

The independent data safety monitoring board found the clinical trial needs to keep enrolling patients and gather results to show if the treatment works.

By Nick Paul Taylor • Oct. 18, 2021

Anatomy of a medical device recall: How defective products can slip through an outdated system

"It truly is like we are operating in about the 1950s," one consultant noted of the process. The FDA has held two meetings in the past year to mull improvements.

By Ricky Zipp • Oct. 18, 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

EU proposes to delay IVD Medical Device Regulation, citing COVID-19 backlog

Originally set to go into effect in May 2022, a progressive rollout is now planned. The proposal will now go to the European Parliament and Council for adoption, according to the announcement.

By Kim Dixon • Updated Oct. 14, 2021

Boston Scientific, Sterigenics potential targets of EPA ethylene oxide reporting requirements

The agency has written to the operators of 31 medical device sterilization facilities, outlining its plans and requesting information to inform its final decision.

By Nick Paul Taylor • Oct. 14, 2021

Abbott, Dexcom could benefit from CGM use jump among Type 2 diabetes patients: report

The population could drive the next wave of demand for devices to track and control diabetes, Jefferies analysts predict, based on polling of roughly 50 endocrinologists and general practitioners.

By Susan Kelly • Oct. 13, 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

FDA breakthrough nods go to liquid biopsies for Alzheimer's, cancer drug response

The agency gave the designation to Quanterix's blood test, which has the potential to aid evaluation of people who present with cognitive impairment, and Nonagen Bioscience's non-invasive bladder cancer test.

By Nick Paul Taylor • Oct. 12, 2021

European Commission adds 2 modules to delayed Eudamed database, with no follow-on timeline

Sections on UDI/device registration, and Certificates and Notified Bodies are now available for voluntary use but some features are missing.

By Nick Paul Taylor • Oct. 12, 2021

Medtronic's surgical robot Hugo gains CE mark, setting up Intuitive faceoff

The system will hit the European market after the medtech giant unveiled it in 2019 and delayed the timeline amid the pandemic. Medtronic will take on market leader Intuitive Surgical and an upcoming product from J&J.

By Ricky Zipp • Oct. 11, 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

FDA beefs up surgical stapler oversight after injuries, death reports

While medtechs like J&J and Medtronic backed the broad change, the final rule held firm on several contentious elements. The agency also updated labeling guidance of both staplers and staples due to patient safety risks.

By Nick Paul Taylor • Oct. 8, 2021

Will a software bill of materials help or hurt medical device cybersecurity?

President Joe Biden's executive order calls for SBOMs, and the FDA wants to require premarket submissions to have an inventory of third-party device components. AdvaMed is concerned the data could be exploited by hackers.

By Greg Slabodkin • Oct. 7, 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

Boston Scientific inks $1.75B deal for Baylis, biggest in string of M&A

SVB Leerink analysts wrote the acquisition will add needed support in electrophysiology and structural heart, two of the highest growth markets within cardiology. It's the medtech's fifth acquisition of 2021.

By Ricky Zipp • Oct. 6, 2021

EU shares guide to MDR's 22 rules for classifying medical devices

If a manufacturer and notified body dispute a classification, the case may be referred to the competent authority in the country where the company has its registered place of business.

By Nick Paul Taylor • Oct. 6, 2021

Medtronic expands 2 MiniMed insulin pump recalls on ring flaw, cyber risks

The recalls have hit the medtech giant at a time when competitors Insulet and Tandem are ramping up in the insulin pump market and amid flagging sales in its diabetes unit.

By Susan Kelly • Oct. 5, 2021

FDA resists industry push to nix De Novo inspections in final rule

"The most controversial aspect was FDA's provision for ... an FDA inspection for what is tantamount to a 510(k)," noted Bradley Merrill Thompson, attorney at the law firm Epstein Becker Green.

By Nick Paul Taylor • 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