FDA-medtech consortium offers strategy to boost patient engagement in clinical trials

The MDIC report, created by a working group including Exact Sciences and J&J, follows the agency's late 2019 draft guidance meant to increase the influence of patients in medical device clinical trial design. 

By Nick Paul Taylor • April 7, 2021

Nevro shares full diabetic neuropathy SCS data as it pursues blockbuster opportunity

If successful, the company would be the only FDA-approved spinal cord stimulation device with an on-label indication for painful diabetic neuropathy. Nevro estimates a market worth up to $5 billion, but analysts are skeptical.

By Nick Paul Taylor • April 7, 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

Medtechs top pharma in cash to doctors for consulting, travel: Health Affairs study

The majority of sector payments, also covering royalties, speaking fees and food, came from the likes of Medtronic, J&J, Zimmer, Stryker and Abbott. Specialties targeted included neurosurgery, orthopaedics and cardiology. 

By Ricky Zipp • 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

FDA warns of patient deaths tied to reusable urological endoscopes

The agency is sounding the alarm after receiving more than 450 adverse event reports in four years tying patient infections to the devices. Products from Olympus and Karl Storz were cited in the reports.

By Susan Kelly • Updated 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

Medtronic inks value-based care pact with Spectrum Health

The risk-based deal, initially focused on cardiac resynchronization therapy, will have the medtech giant paying the provider if certain patient metrics are not met, according to a spokesperson for the health system.

By Nick Paul Taylor • April 1, 2021

FDA links certain breast reconstruction devices to risk of complications

The analysis found Becton Dickinson's AlloMax and MTF's FlexHD may have higher major complication rates than devices made by companies including AbbVie's Allergan.

By Nick Paul Taylor • April 1, 2021

Quest sells minority share of Q2 Solutions for $760M

IQVIA, which previously owned 60% of Q2 Solutions, will now become the sole owner of the clinical trials laboratory company. Quest and IQVIA established Q2 Solutions as a joint venture in 2015.

By Ricky Zipp • April 1, 2021

FDA panel to probe Endologix, broader stent graft safety in November

An advisory panel will meet for two days as the agency mulls further action to address blood leak risks with the medtech's grafts for abdominal aortic aneurysms, and surveillance strategies for all AAA endovascular grafts.  

By Susan Kelly • Updated Aug. 26, 2021

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

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