Biofourmis Inc. won a breakthrough devices nod from the FDA for its Biovitalshf solution, a digital therapeutic for patients with heart failure with reduced ejection fraction (HFrEF). The company, which is pursuing the de novo pathway for the therapy, plans to launch a pivotal trial next month. Biovitalshf is intended to augment guideline-directed use of heart failure medications to manage patients in combination with traditional pharmacotherapy. The software application integrates physiological monitoring, symptoms and signs reporting, patient engagement, medication management and communications to provide clinicians with personalized and specific recommendations about their medication. Read More
The FDA’s device center has a mantra of sorts when it comes to the details, or lack thereof, in guidance, which is “talk to us early and often.” For device makers eyeing the brain-computer interface (BCI) device space, this mantra has been applied to the question of pivotal study enrollment numbers, suggesting that some sponsors will find their pivotal studies come with a case of sticker shock sufficient to force them to rethink their research and developmental plans. Read More
Around 100,000 medical professionals have registered to learn breast cancer related information through Zhongchao Inc.’s Breast Cancer Tiered Diagnosis and Treatment Improvement Platform in the first half of 2021. It marks one of the earliest efforts conducted for the Healthy China 2030 Guidelines, which aims to increase the overall five-year cancer survival rate by 15% by 2030. Read More
PERTH, Australia – Soft tissue regeneration company Aroa Biosurgery Ltd. completed a A$47 million (US$34.72 million) placement on the Australian Securities Exchange that will allow the company to accelerate and broaden its pipeline. What sets Auckland, New Zealand-based Aroa apart from other regenerative tissue companies is the rate of tissue regeneration with Aroa’s scaffold and its affordability, Aroa founder and CEO Brian Ward told BioWorld. Read More
PARIS – Peek Health SA raised $3.5 million in series A funding to ramp development of its 3D pre-op digital planning tools used in orthopedic surgery. This investment was led by two Portuguese venture capital firms: Grosvenor House of Investments SCR SA and Portugal Ventures SA. Read More
New hires and promotions in the med-tech industry, including: Immunoscape, Lucid Diagnostics, Median Technologies, Metagenomi, Novacyt, PHC Holdings, Pulmatrix, Renalytix, Sapphiros, Venus Medtech. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Artio Medical, Bardy Diagnostics, Progenity. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Aptargroup, BD, Bioventus, Boston Scientific, Consensus Business Group, Draper, EC Healthcare, Graymatters Health, Immunai, Medimaps Group, Medx Xelerator, Medx Ventures Group, Misonix, Nanalysis Scientific, Nebion, One Moon Scientific, Prenetics, Weihai Hengyu Medical Products. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Biofourmis, Cepheid, Fluxergy, Nanovibronix. Read More
