Medtronic plc snagged FDA premarket approval for its recharge-free implantable neurostimulator (INS), Vanta, for patients with intractable pain. The spinal cord stimulator offers up to 11 years of device life, with optimal programming. That represents a 10% improvement on the Dublin-based company’s previous longest-lasting INS, Primeadvanced, and a near doubling of device life compared to Abbott Laboratories’ Proclaim and Boston Scientific Corp.’s Wavewriter Alpha, using the settings recommended in the clinician manuals.
Cymedica Orthopedics Inc. received FDA clearance for its Intellihab system to reduce pain associated with osteoarthritis in the knee. The system uses neuromuscular electrical stimulation to strengthen muscles supporting the knee without requiring typical exercises such as squats that could increase pain and further degrade the joint. Intellihab includes a knee brace that emits the pulses and a smartphone app patients use to track and manage the therapy.
Ortho Regenerative Technologies Inc. received a clinical hold letter from the FDA in connection with its investigational new drug (IND) application to begin a phase I/II trial for Ortho-R. The FDA asked for additional information on chemistry, manufacturing and control for the drug/biologic combination that the company is evaluating as an adjunct to rotator cuff repair surgery.
Synchron Inc. landed $40 million in new funding through a series B fundraising round led by Khosla Ventures. This round brings the total amount raised by the company to $59 million since its founding in 2016. Other participants in the round included Forepont Capital Partners, ID8 Investments, Shanda Group, General Advance, Subversive Capital, and Re.mind Capital as well as Arani Bose and Thomas Reardon. Returning investors included Neurotechnology Investors, Metis Innovative, and the University of Melbourne.
With the rollout of its Avagen test, Avellino Lab USA Inc. hopes to see a significant change in the diagnosis and management of keratoconus, a common cause of blindness. The test quantifies the risk of keratoconus and definitively diagnoses other corneal dystrophies, which are frequently misdiagnosed or undiagnosed until late in their development, when treatment is less effective and vision already impaired.
Hematologists juggle two competing needs, and often multiple lenses, to really see what’s happening in a blood sample. Essentially, they need to see both the veins on an individual leaf and the forest, but lack a digitized system that can provide images of both. Scopio Labs Ltd.’s recently FDA-approved X100 with Full Field Morphology Peripheral Blood Smear (FFM-PBS) application addresses this need by combining computational photography imaging with artificial intelligence tools.
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.
A check up by Khosla Ventures determined that Docbot Inc. was healthy enough for the prominent biotech investor to take the lead in a $4 million series A round. The new funds bring the artificial intelligence company to a total of $8.5 million in capital raised to date. Other participants included Bold Capital Partners, Collaborative Fund and Boutique Venture Partners.
Dariohealth Corp. agreed to acquire Psyinnovations Inc. (dba Wayforward), a behavioral health digital platform, for $30 million. The deal represents Dario's second of 2021, following the acquisition of the digital musculoskeletal company Upright Technologies Ltd. in January. The Wayforward transaction calls for $25 million at closing, with $6 million of that in cash and $19 million in shares of Dario common stock valued at $21.09 per share. In addition, Wayforward will receive another $5 million, if behavioral health revenues exceed a certain threshold in 2022.
