Bipolar disorder (BPD) is disabling, destructive and notoriously difficult to diagnose. Research indicates that up to 40% of patients diagnosed with major depressive disorder or unipolar depression actually have BPD and treating them with antidepressants alone runs an elevated risk of worsening their condition. But the issue is not one-sided: other studies found that 30% to 60% of patients diagnosed with BPD do not meet the clinical criteria for the illness and may be taking powerful mood stabilizers needlessly while failing to receive potentially beneficial therapies. Read More
With top line results from its major phase III RECON study in hand, Axogen Inc. is hoping to expand adoption of its allograft nerve repair product Avance. RECON was designed as a non-inferiority study comparing Avance to nerve cuffs (manufactured conduits) which are commercially available. The study met its primary endpoint for the return of sensory function as measured by static two-point discrimination, and the safety profile was consistent with previously published data. Read More
Developers of artificial intelligence (AI) and machine learning (ML) algorithms in medical radiology tend to think of regulatory approval as the primary hurdle to market, but there is also the question of how to pay for the use of these products. Public and private payers obviously hold the purse strings, but appealing to payers is still not always as straightforward proposition as some would like, reinforcing the notion that coverage and reimbursement still combine to serve as one of the highest hurdles to market for AI and ML. Read More
Samsara Vision Inc. signed a deal with China’s Lansheng Medical Corp. (Myvision) to bring Samsara’s next-generation visual prosthetic devices to mainland China, Macau, the Hanain Province, and Hong Kong. Read More
The EU’s Medical Device Coordination Group (MDCG) has advised the device industry that many manufacturers seem ill prepared for the transition to the Medical Device Regulation (MDR), which will be fully in force for all devices as of May 2024. MDCG said that that any leniency shown after that date will be granted only for devices that address an urgent public health need, potentially leaving many existing authorizations out in the cold. Read More
A lot of eyes are on the World Trade Organization (WTO) Ministerial Conference taking place in Geneva June 12-15, as member countries try to reach a consensus on a proposal that would allow certain members to waive intellectual property (IP) rights on COVID-19 vaccines for at least three to five years. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Beijing Turing Medical, Guardant, Hollister, Icecure, Medtronic, Onkos, Vizient. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Earlitec, Ekso, Lensar, Rune, Si-Bone. Read More
