Radiology Partners, Aidoc talk AI adoption, handling bias, FDA actions

While AI and machine learning technologies have gained popularity in the medtech and healthcare industries, the companies intend to further grow usage in radiology with their recent partnership.

By Ricky Zipp • May 3, 2021

Survey casts doubt on utility of wearable devices in healthcare

Forrester's report, based on interviews with doctors, patients and vendors, suggests data gaps and physician skepticism of the popular products is too high for widespread adoption, although design changes could remedy that.

By Ron Shinkman • April 22, 2021

Explore the Trendline➔

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

Health funding shatters records in Q1, but medtech a bit of a laggard

Medical device companies were a relative outlier, raising $4.6 billion, down 23% from a peak in the fourth quarter last year, while the number of deals declined by almost 11%, according to a CB Insights report.

By Rebecca Pifer • April 20, 2021

FDA scraps Trump-era 510(k) exemption bid in scathing dissection of 'flawed' plan

The agency nixed the proposal, which HHS made without consulting FDA, after strong pushback from Baxter and digital health startups, among other stakeholders, as well as its own staff.

By Nick Paul Taylor • April 16, 2021

iRhythm's future hazy after Medicare pricing saga erases 12-month high

Wall Street analysts project the cardiac wearables maker to lose tens of millions of dollars in revenue in coming years, raising questions about the future of the once-hyped market leader.

By Ricky Zipp • April 13, 2021

Medtronic launches AI-based colonoscopy device in US on heels of FDA clearance

The medtech is the exclusive global distributor of Cosmo Pharmaceutical's GI Genius module, which has been granted De Novo clearance and is compatible with colonoscope video for identifying polyps and lesions. 

By Greg Slabodkin • April 12, 2021

iRhythm shares tank after Medicare rates surprise

CEO Michael Coyle said the wearables company will withdraw its Zio XT cardiac monitor from Medicare fee-for-service segments, adding that he was not optimistic for a reversal.

By Ricky Zipp • April 12, 2021

Medtronic's robotic spine market lead threatened as smaller rivals look to edge in

Medtronic and Globus Medical are currently in a "two pony race" in the space, but market share can be stolen as other companies launch systems and adoption grows.

By Ricky Zipp • April 9, 2021

Fewer heart tests ordered for telehealth patients in pandemic

Research published in JAMA Network Open also found those using the virtual services were more likely to be Asian, Black or Hispanic.

By Susan Kelly • April 6, 2021

Digital health funding hits new high after Q1 rich in megadeals

U.S. digital health companies raised a record $6.7 billion in the first quarter of 2021, putting the industry on track to easily top the $14 billion in investment last year.

By Nick Paul Taylor • April 6, 2021

UCLA engineer calls for mitigation of biases of medical devices

The perspective in the journal Science comes as the FDA has warned of social biases in data used to train artificial intelligence and bias against Black patients using pulse oximeters.

By Nick Paul Taylor • April 5, 2021

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

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