An uneasy calm prevails in the medical devices sector in India following regulatory action to cap stent prices and, more recently, a price data-gathering initiative for certain other products. Is this just the lull before another, more turbulent storm that lies ahead for industry?
India's recent regulatory action to rein in the prices of coronary stents seems to have left the medical devices segment nursing some bruises. However, there are fears that more of such action may be brewing for industry.
Part of the apprehension appears stoked by recent diktats, including a note by India’s health ministry to the Medical Council...
After multiple warning letters and safety communications, the US FDA has decided to block the import of certain endoscopes from Olympus. In total, the agency’s action pertains to 58 device models manufactured by the Japanese firm used in urinary, respiratory, abdominal and pelvic procedures.
From June 30, new European Commission rules will attempt to redress an imbalance in medtech trade between the EU and the People’s Republic of China.
During MD&M East in Manhattan last week, a panel of experts discussed how the Trump administration’s trade policy is affecting manufacturing and offered some ideas on what manufacturers can do to help mitigate the chaos.
Announced after three years of negotiation, the FTA eliminates tariffs on 99% of Indian product types, covering nearly all trade value, and reduces tariffs on 90% of UK products. Although not yet formally signed, the deal is being positioned by the Indian government as “transformative,” with an estimated economic impact of $6.4bn for the UK alone by 2040.
The Milner Institute, the on-campus hub for start-up acceleration at Cambridge University, hosted its annual Pitch Day on July 1. Start-ups Panakeia, PathwayBio and Sentinal4D presented diagnostic technologies.
To succeed in medtech, investors must focus on patient outcomes. Gilde Healthcare says involving patients boosts product effectiveness, access and market success — making it a smart strategy in today’s strained healthcare systems.
Broad participation by EU member states in a new pilot to test a unified procedure for evaluating applications for combined drug and IVD studies shows they recognize its value, says Monique Al, vice-chair of the Clinical Trials Coordination Group.
