What's holding up hospital at home?

Widespread adoption of acute-level care at home models has been hampered by physician reluctance and patchwork reimbursement, though a CMS waiver caused hospital participation to snowball during the pandemic.

By Rebecca Pifer • March 18, 2022

'Not for the faint of heart': Insulet CEO talks Tandem and Medtronic competition, Omnipod 5 launch

Shacey Petrovic spoke to MedTech Dive about the long-awaited launch of its insulin pump, competitors' developing patch pumps and how the Ukraine crisis will impact the industry.

By Ricky Zipp • March 17, 2022

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

US replaces EU as priority market for medtech industry: survey

A survey of more than 100 executives at medical device companies found 89% of medtechs plan to prioritize U.S. regulatory approval going forward. One CEO said the EU's Medical Device Regulation "is killing innovation."

By Nick Paul Taylor • March 16, 2022

GE Healthcare profit forecasts meet estimates; spinoff details remain cloudy

While GE's planned spinoff of its healthcare unit in early 2023 remains on track, the company said business and regional segment details, stand-alone costs and capital structure have yet to be worked out.

By Greg Slabodkin • March 11, 2022

Akili plans to go public as it prepares to market video game treatment

"We've proven that foundation and now it's time to run and scale," CEO Eddie Martucci told MedTech Dive. The company is going public through a $1 billion SPAC, rather than a traditional IPO, which it expects to close in mid-2022.   

By Elise Reuter • March 10, 2022

Intuitive CEO on labor shortages, placements amid the pandemic, new competition

Gary Guthart spoke to MedTech Dive about facing new competitors Medtronic and Johnson & Johnson, and addressed criticism of the cost, safety and effectiveness of robotic surgery.

By Ricky Zipp • March 9, 2022

Sanofi strikes $30M strategic agreement with digital health company DarioHealth

One of several digital health investments by the French pharma company, the five-year agreement will give DarioHealth access to Sanofi's sales teams and also involves integrating some of its partner's products.

By Elise Reuter • March 2, 2022

CMS code seen as major step toward reimbursement for digital therapeutics

Pear Therapeutics CEO Corey McCann said the agency's new HCPCS code for prescription digital behavioral therapy is an important milestone for getting digital therapeutics as a product category covered by more insurance plans. 

By Elise Reuter • Feb. 25, 2022

Roche's Foundation Medicine gets FDA breakthrough device nod in latest designations

Breakthrough status was granted to Foundation Medicine's test to detect molecular residual disease in early-stage cancer after curative therapy. A liquid biopsy from Datar Cancer Genetics was also given the regulatory privileges.

By Nick Paul Taylor • Feb. 25, 2022

Diabetes tech leaders expect another year of growth, innovation as competition soars

MedTech Dive spoke with diabetes technology leaders about what to expect in 2022, the impact of new products and the increasingly competitive market.

By Ricky Zipp • Updated May 12, 2022

Medtronic talks diabetes group's FDA warning letter, new products, supply chain constraints

Ali Dianaty, VP of product innovation and operations for Medtronic Diabetes, spoke to MedTech Dive about the warning letter's impact on product reviews, creating insulin pump patches and navigating the pandemic.

By Ricky Zipp • Feb. 18, 2022

Baxter begins integrating Hillrom, faces supply chain pressures

The recent omicron surge put a damper on the company's margins, as shipping costs and healthcare staff shortages rose. Baxter expects these problems to abate in the short term and sees a long-term boost from the Hillrom acquisition.

By Elise Reuter • Feb. 17, 2022

CDRH digital health chief talks new role with agency, future of the market

Bakul Patel, the Center for Devices and Radiological Health's chief digital health officer, will help FDA meet its 2022-2025 strategic priorities and set regulatory policies for the new technologies such as AI and machine learning.

By Elise Reuter • Feb. 14, 2022

Dexcom's G7 gains CE mark after 2021 delay

The company’s newest continuous glucose monitoring system was expected to launch in Europe in 2021, but regulatory delays pushed the release back.

By Ricky Zipp • Updated March 14, 2022

BioCardia, Cook Medical land FDA breakthrough nods in latest designations

Cardiovascular devices feature prominently in the tech granted regulatory privileges, including a drug-eluting stent for patients with chronic limb-threatening ischemia and a non-invasive cardiac monitoring device. 

By Nick Paul Taylor • Feb. 9, 2022

Zimmer gives investors first look at its dental and spine spinoff

The new, independent company, called ZimVie, is expected to bring in about $1 billion in revenue this year. While the dental unit is expected to grow immediately, the spine unit is projected to drop initially.

By Ricky Zipp • Feb. 8, 2022

Procedure volatility, testing uncertainty & FDA delays: Medtech trends in 2022

As companies manage through the omicron surge, and with the threat of potential future variants, the medical device industry is facing another challenging year.

Feb. 4, 2022

3 key FDA topics for medtechs in 2022

While the agency is looking to get back to normal operations this year, COVID-19 is poised to remain a top priority and, once again, thin resources for more traditional work, such as product reviews.

By Ricky Zipp , Greg Slabodkin • Feb. 1, 2022

FDA must improve medical device interoperability through data standards: JAMA

The authors list a range of potential positive outcomes of improved device interoperability, using the experience of the consumer technology and telecommunications industries to make their case.

By Nick Paul Taylor • Jan. 31, 2022

4 key trends for procedure-reliant medtechs in 2022

Medical device companies likely will face the same challenges this year that they have been dealing with since the pandemic's start, such as procedure volatility and hospital staffing shortages.

By Ricky Zipp • Jan. 27, 2022

FDA finalizes two guidances on including patient perspectives in medtech clinical trials

The documents, which elaborate on how to engage patients to improve trial design and use patient-reported outcomes, are based on feedback from groups like AdvaMed which raised concerns about "significant" legal issues.

By Nick Paul Taylor • Jan. 26, 2022

The shifting digital health investment landscape in 2022

Signs point toward another historic year in VC investment, experts say, which will benefit the medical system as it evolves to include more digital services.

By Rebecca Pifer • Jan. 25, 2022

Medtronic's HawkOne recall labeled Class I, adding to medtech's product safety problems

FDA posted 10 Class I recall notices for Medtronic in 2021 and three so far this year. CEO Geoff Martha addressed the recalls and an FDA warning letter at the J.P. Morgan conference, claiming the company will increase accountability.

By Ricky Zipp • Jan. 21, 2022

Digital health funding jumps to new high as investors bet big on mental health startups: report

The explosive growth was driven by digital therapeutics and mental health technology, both of which saw capital inflows more than double compared to 2020, according to a new CB Insights report.

By Nick Paul Taylor • Jan. 21, 2022

Tandem CEO on Omnipod 5 competition, pharmacy distribution, Type 2 growth

John Sheridan spoke to MedTech Dive about international growth, creating an insulin pump system for Type 2 patients and what Insulet's Omnipod 5 launch and Medtronic's FDA warning letter mean for Tandem.

By Ricky Zipp • Jan. 20, 2022