The amount of money raised by medical technology companies in 2021 has dropped by about 26% in comparison with the same timeframe last year, although amounts from IPOs and venture capital rounds have more than doubled. By this point in 2020, $31.48 billion was raised through 282 transactions, while 2021 has so far brought in $23.3 billion through 311 financings, a 10% higher volume. Read More
LONDON – The U.K. health technology assessment agency, NICE, has called for a halt to the use of transvaginal laser therapy in the treatment of urinary stress incontinence and vaginal atrophy, saying there is not enough evidence of long-term safety, or proof that the procedures are effective. Read More
The European Commission unveiled its third alternative to providing global access to COVID-19 vaccines and treatments just ahead of the June 8 meeting of the World Trade Organization’s Council for Trade Related Aspects of Intellectual Property Rights and the start of the G7 summit. Read More
Imagine an orthopedic implant that not only accelerates bone healing but also captures data to support real-time clinical decisionmaking. That’s the vision of Intelligent Implants Ltd., whose Smartfuse system recently won FDA breakthrough device designation. The first indication is for lumbar spinal fusions. Read More
The decision by the U.S. Centers for Medicare & Medicaid Services (CMS) to suspend the Medicare Coverage of Innovative Technology (MCIT) rule a second time was controversial, but CMS’s Tamara Syrek Jensen vowed that the agency has made no final decision. Jensen acknowledged that the agency has not foreclosed a full-blown rescission of the MCIT proposal, a not-implausible outcome given the prospect that legislation in the works in the House Energy and Commerce Committee could render the rule moot. Read More
The Guangzhou Sino-Israel Bio-industry Investment Fund (GIBF) has raised more than half of its proposed ¥2 billion (US$313 million) round. “The second fund, GIBF2, will focus on Israeli and European biotechnology companies, which are developing innovative drugs and are in phase II to III clinical trials,” Avner Lushi, the CEO and co-founder of the GIBF, told BioWorld. Read More
The American Clinical Laboratory (ACLA) filed an appeal to revive its lawsuit against the U.S. Health and Human Services challenging HHS’ overhaul of the medical clinical lab fee schedule over its “harmful regulatory overreach” that imposes an “unsustainable reimbursement model.” Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Agendia, Caredx, Cergentis, Guard Medical, Histosonics, Medtronic, Nyxoah, Prelude, Renovacare. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Allelica, Bruker, Cardiac Insights, Elekta, Entegris, Heliodx, Icecure Medical, Inteneural Networks, Ktrfios Importacao E Exportacao, Neovasc, Philips, Rushnet, Suralign Holdings, Thermo Fisher Scientific. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Avacta Group, Medtronic, Opgen, Orasure Technologies. Read More
