Building trust in new technology for remote patient care requires powerful device infrastructure

Here's what organizations need to know about building trust with patients for device-based care.  

May 16, 2022

Dexcom, Insulet, Tandem start 2022 with revenue growth after weathering omicron surge

All three diabetes technology companies reported that omicron pressured business in January before easing as the quarter progressed.

By Ricky Zipp • May 13, 2022

Dexcom Chief Tech Officer Leach discusses G7's European launch and FDA review, expanding Dexcom One

The executive also comments on the continuous glucose monitor maker's next steps for the G7 system as well as its plans for reaching new patients and expanding to non-diabetic users.

By Ricky Zipp • May 10, 2022

Insulet CEO Petrovic to step down on June 1 due to personal reasons; Hollingshead named sucesssor

Shacey Petrovic, who has served as CEO since 2019, is resigning in the first months of the Omnipod 5 launch, an anticipated product for the diabetes tech space. Jim Hollingshead, an Insulet board member since 2019, will take over.

By Ricky Zipp • May 6, 2022

Biden should send 'clear' message to semiconductor industry on prioritizing medtech, AdvaMed says

The trade group said it's pushing for the prioritization of medtechs, transparency for future allocations to the industry, and actions to ensure the continuity of patient care in the U.S.

By Nick Paul Taylor • May 4, 2022

GE Healthcare hit by supply chain constraints, inflation pressures

"We're operating in a challenging macro environment," GE CEO Larry Culp said during a first-quarter earnings call, while also noting COVID-19 lockdowns in China and lower sales volumes in Russia and Ukraine impacted results. 

By Greg Slabodkin • April 26, 2022

Pear's VR product for postoperative pain granted FDA STeP designation

The agency's designation under the Safer Technologies Program for medical devices could expedite regulatory review for the virtual reality-based digital therapeutic, one of several products in Pear's pipeline.

By Elise Reuter • April 14, 2022

Digital health funding dropped in Q1 to lowest level since 2020: CB Insights

The report is directionally in line with the findings of an earlier report from Rock Health, which described how the drying up of deals in February and March may be an early sign of a correction in digital health venture capital funding.

By Nick Paul Taylor • April 14, 2022

Can digital therapeutics become profitable?

As more software-based treatments gain FDA clearance, they still face hurdles ahead in getting insurance reimbursement and garnering adoption among patients and physicians.

By Elise Reuter • April 11, 2022

Medtronic's recall of over 175,000 MiniMed pumps labeled Class II by FDA

The recall, which will not require the retrieval of any devices, has been associated with serious injuries and one death, according to the company. Medtronic said an independent review did not attribute the death to the issue.

By Ricky Zipp • Updated April 8, 2022

iRhythm builds case for wearable cardiac monitor with data in fainting, TAVR patients

Data presented at ACC's Scientific Sessions show that by using iRhythm's Zio to monitor patients after discharge, physicians reduced hospital stays and potentially improved identification of arrhythmia.

By Nick Paul Taylor • April 4, 2022

Pear expects $22M in revenue this year, as it banks on growing adoption of digital therapeutics

Pear still has substantial challenges going forward, as it faces several unknowns about the long-term adoption and reimbursement of its products. The company has been operating at a net loss, seeing a $65 million loss last year.

By Elise Reuter • March 29, 2022

FDA asks Congress for 14% bump in device budget for supply chain, cybersecurity programs

For the devices program, the FDA is asking for roughly $698 million, with approximately $466 million from the budget authority and $232 million from user fees.

By Nick Paul Taylor • March 29, 2022

Google launches new search tool for provider appointments, seeks FDA approval for Fitbit feature

The tech giant is working to prop up its healthcare efforts following internal project shakiness that led the company to dismantle its Google Health business last year.

By Rebecca Pifer Parduhn • March 28, 2022

The case for hybrid care models

Telehealth is increasingly being woven into healthcare organizations' future plans, giving hope to proponents of hybrid care models.

By Rebecca Pifer Parduhn • March 22, 2022

Dexcom's hospital glucose monitor leads latest FDA breakthrough designations

The regulatory privileges were granted to Dexcom after its at-home glucose monitors were allowed to be used in hospitals during the pandemic. AltPep, CardioStory, Insightec and Merit were also among the designations this month.

By Nick Paul Taylor • March 22, 2022

Your consent can make or break your studies

Consent is a critical part of the patient journey, but ensuring patients are fully informed and willing to participate in a trial is an ongoing process. Discover best practices to achieve continuously informed consent.

March 21, 2022

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 Parduhn • 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

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