Looking to increase adoption among more tobacco users, Carrot Inc. expanded the indications for use of its smoking cessation breathalyzer with a new FDA 510(k) clearance to include the claims related to a recent study in the labeling and promotion of the sensor. The clinical trial demonstrated the Bluetooth-enabled sensor’s ability to increase a person’s motivation to quit.

PARIS – One year on from launch, Digitale Gesundheitsanwendungen (DiGA), or digital health applications, are gaining widespread acceptance in Germany. Digital therapeutics (DTx) have been available since 2020 to the 73 million people in Germany covered by public health.

PARIS – Aptargroup Inc. is negotiating to buy Voluntis SA in a move that would complement its existing digital solutions portfolio and expand services to address multiple conditions and chronic diseases. "By being part of Aptar, we will be able to pursue a common ambition aimed at providing a complete digital health platform combining connected devices and digital therapeutics," Pierre Leurent, CEO and co-founder of Voluntis, told BioWorld.

Pear Therapeutics Inc. has joined a growing number of med-tech startups that are merging with special purpose acquisition companies (SPACs) as a backdoor pathway to an initial public offering (IPO). On Tuesday, Pear, a company developing digital therapeutics, reported plans to combine with Thimble Point Acquisition Corp., a blank check company affiliated with the Pritzker Vlock Family Office (PVFO), in a deal valued at approximately $1.6 billion. The $400 million in gross proceeds, including roughly $276 million in cash held in Thimble’s trust account and about $125 million, at $10 per share, from an oversubscribed PIPE (private investment in public equity), will be used to further commercialize Pear’s three FDA-authorized products, advance its pipeline and scale its end-to-end platform.

It’s not unusual for women to have some uterine contractions during pregnancy. Many of these go unnoticed, but others can be strong and feel like labor. Distinguishing between normal contractions and those that are not can help ensure women at risk of preterm labor get the extra medical care they need. To that end, Tel Aviv-based Nuvo Group Ltd. has launched an FDA-cleared uterine activity (UA) module on its Invu remote monitoring platform.

As demand for artificial intelligence (AI)-driven health assessment platforms grows, software developer Ada Health GmbH has signed more than 10 new partnerships with key players across life sciences, insurance and health systems. These include pharmaceutical partners Takeda Pharmaceutical Co., Sanofi SA, Alnylam Pharmaceuticals Inc., as well as Taj Digital Health, Sutter Health, and more.

Dsruptive Subdermals AB has completed a clinical showing body temperatures tracked by its chip implants are comparable to temperature readings from standard clinical thermometers. The Stockholm-based startup is now offering its injectable implants as an open platform for researchers seeking efficient, low-cost tools to monitor changes in body temperature.

Alivecor Inc. has elevated its patent dispute with Apple Inc. to the U.S. International Trade Commission (ITC) in a move that could damage the latter’s foray into digital health. Alivecor is alleging that Apple, of Cupertino, Calif., has infringed on Alivecor patents for electrocardiogram monitoring technology, a development that may foreshadow a continuing legal struggle between the two companies for a large and rapidly growing market.

Woebot Labs Inc. got a bit of a pick-me-up with the FDA's decision to grant breakthrough device designation to the company's digital therapeutic for postpartum depression. The WB001 app combines cognitive behavioral therapy with interpersonal psychotherapy and an understanding of how postpartum depression affects interactions and daily life. The investigational treatment is designed as an eight-week, prescription-only intervention for women under a physician’s care.

With the support of the NIH’s National Institute of Child Health and Human Development and the National Institute of Mental Health, researchers at Duke University’s Center for Autism and Brain Development have developed a mobile app that can quickly screen toddlers for autism spectrum disorder without the need for specialized skills.