Analysts tip surgeries to rebound. Rising COVID-19 cases threaten those forecasts.

Two Wall Street reviews suggest people are visiting hospitals more and are increasingly comfortable with undergoing elective care, but they come amid the CDC chief's warning that rising hospitalizations may jeopardize progress.

By Nick Paul Taylor • March 30, 2021

Helius gets FDA nod for neuromodulator after pivoting to multiple sclerosis

The non-implantable device delivers neuromuscular stimulation to an MS patient's tongue, sending electrical signals to the central nervous system as a short-term treatment of gait deficit.

By Nick Paul Taylor • March 29, 2021

Explore the Trendline➔

Top 5 stories from MedTech Dive

From haphazard layoffs at the Food and Drug Administration to the industry’s current IPO environment and tracking FDA-authorized AI devices, here is a collection of top stories from MedTech Dive.

By MedTech Dive staff

Medtronic's Harmony pulmonary valve wins FDA approval

The device is the first non-surgical heart valve cleared in the U.S. to treat a severe form of pulmonary valve regurgitation that usually results from a congenital heart defect.

By Susan Kelly • March 29, 2021

Boston Scientific links just approved liver cancer device to improved survival

Analysts at Evercore ISI estimate FDA clearance for the radioactive glass beads opens up a $150 million U.S. market opportunity, although they note lack of data from a randomized trial "could be a factor in modeling adoption."

By Nick Paul Taylor • March 26, 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

Boston Scientific to pay $188.6M to settle mesh claims in 47 states

The agreement with the attorneys general settles allegations the medtech giant misrepresented or failed to disclose to patients all of the potential risks involved with the vaginal implants.

By Susan Kelly • 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

FDA grants EUA to COVID-19 screening device using machine learning

While the product gives institutions another screening tool for those without symptoms, Tiger Tech faces competition with antigen testing scaling up. 

By Nick Paul Taylor • March 22, 2021

ASCs gave medtechs alternate care sites amid pandemic hospital elective shutdown

After surgeries moved to ambulatory surgery centers during the pandemic's upending of non-emergency care, experts and industry believe some procedures may never go back.

By Ricky Zipp • March 19, 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

Robotics demand held firm as pandemic pummeled electives

Intuitive Surgical, Stryker and Zimmer Biomet all saw procedure volumes drop in 2020 as electives shut down. However, system demand remained strong despite the financial hit to hospitals.

By Ricky Zipp • March 18, 2021

Abbott halts trial enrollment for HeartMate PHP catheter blood pump

The move is due to a report of a device malfunction, amid a history of setbacks for the technology. The study was comparing the catheter head-to-head with Abiomed Impella pumps.

By Ricky Zipp • Updated 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

CMS puts the brakes on breakthrough device coverage rule

The policy would automatically OK Medicare reimbursement for devices with FDA breakthrough status, but critics contend the rule would undermine CMS authority to consider the clinical evidence backing new technologies.

By Susan Kelly • March 16, 2021

FDA flags risk of device fracture in Colfax's STAR ankle replacements

The products, recently divested to Colfax from Stryker, showed fractures occurring as early as three to four years after implant in an FDA analysis of post-approval study data and adverse event reports.

By Susan Kelly • March 16, 2021

Bayer posts second analysis of Essure adverse events taken from social media

The latest data shows reports of 11,830 serious injuries, 45 malfunctions and nine deaths, but the FDA advised against drawing conclusions. Bayer pulled the device from the U.S. market in 2018 and still defends its safety.

By Nick Paul Taylor • Updated March 17, 2021

1 year after COVID-19 hit: what's next for FDA, electives, testing and robotics

The medtech industry has ridden a roller coaster of steep demand for novel diagnostics and a plunge in once-stable business lines like hip and knee replacement surgeries.

March 15, 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

Cardinal Health sells troubled Cordis unit to private equity firm for $1B

Hellman & Friedman's acquisition of the maker of interventional vascular technology follows Cardinal's 2015 buy of Cordis from Johnson & Johnson for $1.9 billion.

By Greg Slabodkin • March 12, 2021

Hospitals lift curtain on prices, revealing giant swings for hips, knees and more

At a Sutter hospital in San Francisco, a joint replacement ranges from $22,865 to $101,571, accordind to a Healthcare Dive analysis of data hospitals are required to report as of January. 

By Samantha Liss , Nami Sumida • March 11, 2021

CMS pushes back kidney care payment model start date to January 2022

The rule incentivizes delivery of at-home dialysis care with increased payments. Baxter and Outset Medical are among those that pushed for the changes.

By Rebecca Pifer • March 11, 2021

Docs writing in NEJM push CMS to drop breakthrough payment rule

Rescinding the rule would stop a change analysts saw as a "significant commercial tailwind" for companies including Abbott, J&J and Medtronic.

By Nick Paul Taylor • March 11, 2021