The US FDA released four close-out letters in June and July, publicly resolving warning letters issued to manufacturers of wound dressings, artificial hips, IUDs and disposable electrodes.

The 20 September deadline for proposals takes the EU one step closer to the appointment of the first new Innovative Health Initiative IHI consortia involving medtech.

A manufacturer and importer of COVID-19 tests was cited for distributing unauthorized devices as well as GMP violations in the only warning letter issued to a medtech company last month.

While each new designation of a notified bodies in the medtech space is good news, many more organizations are needed rapidly to help manage growing demand. Capacity warnings continue.

The US Departments of Health and Human Services and Justice have published guidance on protections in federal laws to help Americans with disabilities or limited English proficiency to access telehealth. The guidance coincides with the 32^nd anniversary of the American with Disabilities Act.

The app, the first to be approved with a birth control indication, can now sync data directly from the Oura Ring, a wearable device that tracks user’s biometrics.

The US FDA released four close-out letters in June and July, publicly resolving warning letters issued to manufacturers of wound dressings, artificial hips, IUDs and disposable electrodes.

The 20 September deadline for proposals takes the EU one step closer to the appointment of the first new Innovative Health Initiative IHI consortia involving medtech.

The US FDA is now allowing users to submit 510(k), PMA, and other premarket applications through its Customer Collaborations Portal, which previously only allowed users to track submissions.

Although procedure volumes have mostly recovered from the shock of COVID-19 two years ago, the effects of the pandemic on the medtech sector and the economy overall will be felt for years to come. In recent analyst and sales and earnings presentations, CEOs of major medtech companies faced questions about how their company is handling these major "macro" issues.

Zimmer Biomet agreed to amend its exclusive development and distribution agreement with NeuroOne to pay $3.5m for 350,000 of stock. The deal will help NeuroOne continue to develop its Evo stereoelectroencephalography brain-mapping electrodes without further diluting the company’s stock.

The US FDA is now allowing users to submit 510(k), PMA, and other premarket applications through its Customer Collaborations Portal, which previously only allowed users to track submissions.

An interactive view of medtech executive changes from the month of July 2022.

The app, the first to be approved with a birth control indication, can now sync data directly from the Oura Ring, a wearable device that tracks user’s biometrics.

After six months, the Omnipod 5 has seen its limited market launch expanded to cover the entirety of the US market.

Withings’ health division is partnering with Medable to facilitate decentralized clinical trials.

The pharmaceutical company has made a bold play to expand its presence in the device space, giving iSTAR upfront cash in a deal that grants it the right to buy iSTAR for almost half a billion dollars.

Abbott continued St. Jude Medical’s prior research on deep brain stimulation for treating depression and has advanced the technology far enough that the US FDA now believes it could be a breakthrough treatment for treatment-resistant depression.

The Supreme Court’s June decision overturning Roe v. Wade has sown confusion among abortion service providers, including in telehealth contexts, as a new legal framework develops across the US.

Lumos Diagnostics is considering an appeal of the agency’s decision to refuse market clearance for its FebriDX test.

Eko’s Murmur Analysis Software is the first and only electronic stethoscope software identify and differentiate sounds indicative of valvular heart disease from so-called “innocent” heart murmurs.