Liquid biopsy startup Delfi Diagnostics Inc. scooped up $100 million in a series A round led by Orbimed Advisors LLC. The company will use the funds to grow its team of cancer researchers and machine learning experts and to validate its next-generation blood-based testing technology in prospective clinical trials. Existing investors Menlo Ventures, Samsara Biocapital, Illumina Ventures, Av8 Ventures also participated in the round, along with new investors Foresite Capital, Northpond Ventures, Cowen Healthcare Investments and Rock Springs Capital. Read More
The Medicare Coverage of Innovative Technology (MCIT) program drew rave reviews when it was unveiled, but the associated proposal to redefine the term “reasonable and necessary” met with skepticism. The final rule includes some discussion of how private payer coverage might be leveraged to broaden the definition, but the Centers for Medicare & Medicaid Services (CMS) nonetheless punted on the question for now, promising to tackle it within a year. Read More
Medtronic plc reported that the first patient has been enrolled in the Adaptive DBS Algorithm for Personalized Therapy in Parkinson's Disease (ADAPT-PD) study its trial evaluating the safety and efficacy of adaptive deep brain stimulation (aDBS) in patients with Parkinson's disease (PD). This type of stimulation is an investigational feature of the Percept PC device that could be enabled if approved. Read More
The volume of med-tech deals and M&As in 2020 reached impressive levels, well above 2019, primarily due to the demands of a global pandemic, although the disclosed values of those alliances fell dramatically short. Even so, the spotlight that shined on digital health and diagnostics throughout the challenging year has potentially set up the med-tech industry for an influx of attention going forward. Read More
PERTH, Australia – Perth-based regenerative medicine company Orthocell Ltd. saw its shares rise 27% on the heels of its first U.S. approval for its collagen medical device for dental guided bone and soft tissue regeneration applications. “It’s an important milestone for us, and one that came quicker than I was expecting it to come,” Orthocell CEO Paul Anderson told BioWorld. The company submitted its 510(k) application to the FDA in May, and he was expecting approval by the middle of 2021. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Hyperfine Research, Novaerus, Perkinelmer, Perspectum. Read More
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: HHS examines device classification process at FDA; NIH offers NGS system for SARS-CoV-2; FDA issues pandemic policy for coagulation systems. Read More
Keeping you up to date on recent developments in diagnostics, including: Improving diagnosis of brain diseases; Predicting survival of COVID-19 patients; New causal gene for chronic kidney disease. Read More
