Ventura Capital has led a $60 million series A investment round into consumer genetic testing company Dnanudge Ltd. It is the first major fundraising round for the London-based company, which will be used to accelerate deployment of its DNA testing service worldwide. Dnanudge is aiming to tap into the lucrative consumer DNA testing market with Dnaband, a wearable device that stores digital DNA and helps users make healthier choices by personalizing shopping behaviors. The company is also planning a service for personalized skincare shopping. Read More
The Medical Device Innovation Consortium (MDIC) has launched a digital health initiative that will aid the FDA in its efforts to devise a workable regulatory system for these products, which includes a work stream for change control. This work stream promises to be a massive effort, but Joe Sapiente, MDIC's vice president for clinical science and technology, told BioWorld that MDIC needs subject matter experts in this and several other areas to sustain the group’s momentum and thus aid the FDA’s efforts to produce guidance for digital health products. Read More
Onkos Surgical Inc. nabbed an additional $15 million from its existing investors in a series C fundraising round. The Parsippany, N.J.-based company plans to use the new cash to accelerate research and development for its product line which is designed to meet the specialized needs of oncology patients who require orthopedic surgery and the surgeons who work with them. Read More
PERTH, Australia – Australia’s Therapeutic Goods Administration (TGA) has initiated proceedings in the Federal Court of Australia against Medtronic Australasia Pty Ltd. for alleged unlawful supply of its Infuse bone graft kit, which contains a medicine and other components to stimulate bone growth in patients. Read More
Once upon a time, Intarcia Therapeutics Inc. was a biotech unicorn valued at $3.5 billion. Its allure was its implantable Medici drug delivery system that consisted of a mini pump about the size of a matchstick. But a unicorn’s life is never completely charmed. Intarcia faced obstacles along the way – two complete response letters from the U.S. FDA and the denials of three formal dispute resolution requests. Now it looks like this story won’t have a happy ending. Read More
New hires and promotions in the med-tech industry, including: Avisa Diagnostics, Integrated DNA Technologies, Kaia Health, Pillar Biosciences, Promaxo. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Alphabet, Astrazeneca, Biolife Solutions, Bionano Genomics, Boston Scientific, Gray Matter, Insilico Medicine, Inventia Life Science, Lumenis, Nuprobe Global, Pear Therapeutics, Sexton Biotechnologies, Signalpath, Thermo Fisher Scientific, Verily Life Sciences, Xylyx Bio. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Asensus Surgical, Endosound, Immunolight, In2bones, Intelivation Technologies, Rehabtronics, Tyber Medical. Read More
