Apple Watch monitoring features for AFib, Parkinson's cleared by FDA

With the new feature, atrial fibrillation patients may have an easier way to track the frequency of the condition over time and see whether lifestyle changes may have positive effects.

By Nick Paul Taylor • June 14, 2022

Insulet targets competitive conversions as Omnipod 5 insulin pump nears full launch

The company said at a conference it aims to increase the rate of insulin pump use among people with Type 1 diabetes in the U.S. 

By Nick Paul Taylor • June 9, 2022

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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

Dexcom CEO Sayer on G7 FDA submission, developing a 15-day sensor, M&A plans

Kevin Sayer spoke about the company's back-and-forth with the FDA on the G7 CGM system, possibly expanding from a 10-day to a 15-day sensor and on a report that Dexcom was in talks to buy Insulet.

By Ricky Zipp • June 7, 2022

Pear sets out payer strategy as it seeks to quadruple prescriptions of digital therapeutics

Pear shared real-world data that linked its digital therapeutic for substance use disorder to an estimated $3,591 reduction in per-patient costs.

By Nick Paul Taylor • June 7, 2022

Verily advances smartwatch toward Parkinson's clinical trial use after validating technology

The researchers concluded the wearable device could reduce the sample size needed to show the effect of a therapeutic intervention.

By Nick Paul Taylor • May 25, 2022

How a Dexcom-Insulet combination would shake up the diabetes treatment industry

Following a Bloomberg News report that Dexcom is in talks to buy Insulet, analysts say such a move would put competitors in a "tough spot."

By Ricky Zipp • May 25, 2022

Dexcom says it's not in acquisition talks

Bloomberg News reported last week that the company was seeking to buy Insulet.

By Ricky Zipp • Updated May 31, 2022

AI and RWD in HCP engagement – here's the secret to effective execution

Rethink your approach to AI and RWD and turn ideas into actionable strategies for medtech marketers.

May 23, 2022

Google hires former FDA digital health officer to global strategy post

In his new role, Bakul Patel will help Google build a unified digital health and regulatory strategy.

By Samantha Liss • May 19, 2022

Pear more than doubles revenue from last quarter, shares new economic data

The company is keeping its 2022 revenue forecast of $22 million. Pear also presented economic data, which analysts said would be important in conversations with payers.

By Elise Reuter • May 17, 2022

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 • 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 • March 22, 2022