Liquid biopsies dominate FDA's latest breakthrough device nods

Cancer tests feature heavily in the latest round of agency breakthrough designations, with Natera, Inivata and Bluestar Genomics all securing the status.

By Nick Paul Taylor • April 5, 2021

Stryker, Zimmer make data and analytics a top priority as robotic procedures ramp up

Through partnerships with big tech or developments of smart implants, the orthopaedic companies say tapping troves of patient data is the next logical strategic step.

By Ricky Zipp • March 25, 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

Drugmakers flock to Vineti's fix for a cell, gene therapy problem

The San Francisco-based tech company wants to establish a patient identifier akin to a digital ID badge that could work for all types of advanced medicines and improve traceability, control costs and better ensure patient safety. 

By Jacob Bell • March 24, 2021

Baxter, digital health startups lead pushback against 510(k) exemptions

Companies argued in public comments that relaxing certain FDA regulations could put consumer safety at risk. Roche was a rare supporter, arguing the changes would "free up much needed FDA resources."

By Nick Paul Taylor • March 23, 2021

Insulet's Omnipod 5 trial shows benefits across patient groups with Type 1 diabetes

The long-awaited results showed a reduction in blood sugar levels and increase in daily time spent in desired blood sugar ranges for younger and older patients. Wall Street analysts called the findings expected but still strong.

By Ricky Zipp • March 22, 2021

CGM patients seen rising 38% in 2021 fueled by Type 2 diabetes: poll

Dexcom and Abbott are expected to benefit the most from the booming space, while Medtronic is expected to lose ground in the Type 1 market, according to an SVB Leerink survey of 101 endocrinologists and nurse practitioners.

By Ricky Zipp • March 18, 2021

FDA touts real-world evidence use by Abbott, Medtronic in analysis of regulatory decisions

The agency has released details of how medtechs have used RWE, such as registries and medical records, to support filings including 510(k) submissions and premarket approval applications.

By Nick Paul Taylor • March 17, 2021

All eyes on elective care after a rollercoaster year for medtech

After shutdowns slammed procedure-dependent firms in 2020, industry and Wall Street are waiting to see when non-emergency surgeries return and what a comeback might look like.

By Ricky Zipp • March 16, 2021

5 things medtech can expect from FDA in 2021

"What you saw under the prior administration was this concept of a kinder, softer FDA to industry," said Dennis Gucciardo, partner at Morgan Lewis. Experts now expect a shift, including more enforcement activity.

By Greg Slabodkin • March 15, 2021

Cardiac wearables, iRhythm, under a cloud as reimbursement questions linger

"If this [Novitas Solutions] rate is not adjusted, these companies don't make money and will be unlikely to provide the service," Baird analyst Mike Polark said.

By Ricky Zipp • March 15, 2021

Quest eyes $2B DTC testing potential to capitalize on 'breakout' consumer growth

The lab giant's next move is to start selling an $89 at-home fecal test, targeting the colorectal cancer screening market led by Exact Sciences' Cologuard.

By Nick Paul Taylor • March 12, 2021

Vast majority of hospitals say they have an AI strategy, up from just half last year

AI technologies have also caught the attention of the medical device industry, with top medtechs like Medtronic, GE Healthcare and Philips investing in the space.

By Rebecca Pifer • March 10, 2021

BD, Abbott using apps to ease COVID-19 antigen test data bottlenecks

Both companies are using apps to capture and store testing data with public health agencies. The U.S. government has invested hundreds of millions of dollars to increase antigen testing, but data sharing hurdles remain.

By Nick Paul Taylor • March 10, 2021

Abbott capitalizes on digital health boom with virtual clinic for neuromodulation therapy

The FDA-approved virtual clinic is the medtech giant's next step to gain share in the neurmod market from rivals Medtronic, Boston Scientific and Nevro.

By Nick Paul Taylor • March 9, 2021

Backing for telehealth Medicare reimbursement gains steam in Congress

Tuesday's House committee mirrored similar Senate panels. There's bipartisan support for a permanent expansion to a greater share of the population, but legislators are split on what form it should take. 

By Rebecca Pifer • March 5, 2021

Insulin pump adoption seen climbing 21% in 2021 on wearables boom: survey

The SVB Leerink poll of 101 endocrinologists and nurse practitioners also projects a shift in market position among top players like Medtronic, Insulet and Tandem Diabetes Care.

By Ricky Zipp • March 5, 2021

Warchests, distressed assets drive medtech M&A flurry early in 2021

The industry is averaging more than one $100 million-plus takeover a week, as the influx of COVID-19 test revenues and pressures on companies reliant on surgical procedures create buying opportunities.

By Nick Paul Taylor • March 5, 2021

FDA lays out data modernization action plan

"Even small advances in our ability to gain useful insights from data can represent significant opportunities," Janet Woodcock and Amy Abernethy, respectively FDA's acting commissioner and acting CIO, wrote.

By Nick Paul Taylor • March 4, 2021

Hillrom steps back from $375M BardyDx deal on reimbursement setback

The hospital products maker said a Medicare contractor's unexpected drop in payment rates for BardyDx's cardiac monitoring technology meant closing conditions for the transaction had not been satisfied.

By Susan Kelly • March 1, 2021

iRhythm still faces reimbursement uncertainty after meetings with Medicare rate negotiator

CEO Michael Coyle said the cardiac monitoring company and other industry representatives met with a Medicare Administrative Contractor twice, but added that there are no assurances rates will come up.

By Ricky Zipp • Feb. 26, 2021

Diabetes wearables look resilient through 2021, bucking broad medtech trends

Dexcom, Tandem and Insulet pointed to targeting Type 2 patients and DTC as growth drivers in posting year-end results. One analyst gushed that "the golden age of diabetes care is still here."

By Ricky Zipp • Feb. 25, 2021

Google opening office near Mayo Clinic campus to galvanize tech collaboration

The goal of the business venture is to form an "AI factory" churning out algorithms and other digital products in a variety of clinical specialties.

By Rebecca Pifer • Feb. 19, 2021

COVID-19 leads to explosion in cyberattacks, data breaches

A survey from CI Security found successful hacks involving healthcare organizations or their business associates soared in the second half of last year, leading to a jump in the number of breached patient records.

By Ron Shinkman • Feb. 12, 2021

Dexcom touts boost from Super Bowl ad, sidesteps access complaints

While acknowledging concerns of the diabetic community, CEO Kevin Sayer said the company has a business to run and "by making more people aware" of CGMs "we'd have a much more positive effect than negative."

By Ricky Zipp • Feb. 12, 2021

Abbott, Medtronic could benefit as spinal cord stim seen rebounding

Physicians plan to prescribe 28% more implants than last year, driving sales above the high hit in 2019, according to a survey of 50 doctors by Baird Equity Research.

By Nick Paul Taylor • Feb. 12, 2021