Important Industry News

FDA funds a new digital health unit
We are quite encouraged by FDA’s recent moves. Last month the agency announced a precertification program for digital health applications. With the establishment of the new unit, we will see a lot more clarity going forward. The unit has a comprehensive agenda covering wireless medical devices, mobile apps, telemedicine, interoperability and others. We say it is about time!

Pear Therapeutics gets de novo FDA clearance of its digital app for substance abuse
The app is designed to be prescribed by clinicians and used alongside counseling. Abuse of alcohol and drugs costs the U.S. $700 billion annually. We believe drug-free digital therapeutics are transformational ways of addressing many diseases including diabetes. The fact that FDA was satisfied with reviewing the results of only a 12-week clinical trial for Pear’s protocol and categorizing such apps as low to moderate risk is a significant step forward for the entire industry.

FDA approves the revolutionary CAR T-cell therapy for acute lymphoblastic leukemia or ALL
To us this approval is one of the most exciting news in medicine in decades. This is bio engineering at its best. Essentially the process is a drug-free treatment where T- cells are separated after the blood is drawn. Next, using a disarmed virus, the T-cells are genetically engineered to produce receptors on their surface called chimeric antigen receptors, or CARs. Thereafter the CAR T-cells are infused into the patient. If all goes well the engineered cells further multiply in the patient’s body and recognize and kill caner cells. Industry expects more protocols to address other type of cancer in the near future.

GE Ventures and NY Northwell Health launch bioelectronics alliance
This was announced earlier in the year but we missed it. Readers recall that last year GSK and Alphabet’s Verily created a $715 million joint venture to work on bioelectronics. The partnership between GE Ventures and Northwell will focus on developing and commercializing new diagnostic and therapeutic solutions for bioelectronic medicine for many conditions including neurodegenerative diseases. The pattern is evident. More and more chronic diseases may be treated without drugs or chemicals. The consequences of this shift are monumental.

Aetna taps Walmart executive to head venture with Apple
It seems that many of the large insurers are eager to hire executives with retail experience. And as wearables become a cornerstone of their wellness programs, we see this trend continuing. Aetna already offers Apple watches to its 50,000 employees.