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Global Healthtech CEO Connect: Software As A Medical Device In The U S And EU Recap | MoFo Life Sciences

To embed, copy and paste the code into your website or blog: On Friday, March 26, 2021, over 180 attendees worldwide attended McKinsey & Company’s first Global HealthTech CEO Connect of 2021. The discussion focused on regulatory and legal considerations for software as a medical device (SaMD) in both the United States and Europe and specific use cases for digital therapeutics and other digital health products. Speakers included Morrison & Foerster partners Bethany Hills and Wolfgang Schönig as well as special guest Corey McCann, president and CEO of Pear Therapeutics, in a fireside chat at the end of the program.  Globally, the convergence of software technology and life sciences creates a massive opportunity for growth, and the market for these products is growing exponentially. Both the U.S. Food and Drug Administration (FDA) and European regulators have focused on establishing a regulatory framework for oversight of SaMD.

DTx company Pear inks slew of deals to integrate more digital biomarkers and a digital pill into platform

(Photo by Klaus Vedfelt/Getty Images) Digital therapeutics company Pear Therapeutics is looking to integrate digital biomarkers, machine learning algorithms and sensor-based technologies into its platform thanks to new licensing deals and partnerships. The Boston-based DTx company has inked collaboration deals with Empatica and etectRx, as well as licensing tech from KeyWise. Specifically, Pear s collaboration with Empatica will focus on the use of medical-grade wearables and digital biomarkers. The company is looking to use wearables to evaluate a patient s withdrawal symptoms from opioids, alcohol and other substances. The etectRx partnership will focus on medication adherence. Pear will now be able to integrate etectRx s digital pill, which can show if a patient ingested the medication. This partnership isn t a surprise. In January, the two companies announced a deal to potentially develop a product that combines the former s DTx with a digital pill offering. At the time, t

Pear Therapeutics and Prescryptive Health Announce Formulary Coverage for Prescription Digital Therapeutics reSET® & reSET-O® for the Treatment of Substance and Opioid Use Disorders

Pear Therapeutics and Prescryptive Health Announce Formulary Coverage for Prescription Digital Therapeutics reSET® & reSET-O® for the Treatment of Substance and Opioid Use Disorders By Staff 2 seconds ago Prescryptive Health, a health intelligence platform focused on improving the prescription drug market and the pharmacy experience, teams with Pear to make innovative prescription digital therapeutics (PDTs) accessible to its members in recovery. Prescryptive Health will offer and administer Pear’s reSET® and reSET-O® through its digital platform as a covered standard pharmacy benefit for people with substance use disorder or opioid use disorder. BOSTON & SAN FRANCISCO & REDMOND, Wash.–(BUSINESS WIRE)–Pear Therapeutics, Inc. and Prescryptive Health today announced that Prescryptive, the first health intelligence platform, will offer and administer benefit coverage for reSET® and reSET-O®, the first two prescription digital therapeutics (PDTs) to receive authoriza

Pear Therapeutics Announces Second Closing of Series D Financing

Company adds a leading national Integrated Delivery Network (IDN) as a strategic investor. The financing supports Pear’s continued efforts to expand patient access for its portfolio of Prescription Digital Therapeutics (PDTs), including reSET®, reSET-O® and Somryst® treating addiction and insomnia conditions, respectively. BOSTON & SAN FRANCISCO–(BUSINESS WIRE)–Pear Therapeutics, Inc., (“Pear” or the “Company”) today announced the second closing of its Series D financing. The second closing included a leading national Integrated Delivery Network (IDN) as a new strategic investor. The national IDN is investing $20 million, bringing the total Series D investment to $100 million. “Pear is pleased to add one of America’s leading health care providers and health plans to our distinguished list of investors as we continue to expand patient access to our FDA-authorized digital therapeutics,” said Corey McCann, M.D., Ph.D., President and CEO of Pear Therapeutics.

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