health_text_en

MedAlliance SELUTION SLR Receives Coronary FDA IDE Approval

Following our communication last  week “MedAlliance to be acquired by Cordis”, MedAlliance is pleased to make the following announcement:  SELUTION SLR™, MedAlliance’s novel sirolimus-eluting balloon, has received FDA Investigational Device Exemption (IDE) approval to initiate its coronary pivotal clinical trial.  This is the first sustained limus release coronary drug eluting balloon (DEB) to receive FDA IDE approval…

thaipr.net

26 ต.ค. 65

SIRONA completes enrollment – A leap in the DCB treatment of femoropopliteal arterial disease

Concept Medical Inc. announces the successful completion of the SIRONA – World’s first and the largest head-to-head RCT investigating the use of Sirolimus Drug Coated Balloon (DCB) (Magic Touch PTA – Concept Medical Inc.) V/S Paclitaxel DCB angioplasty for the treatment of peripheral artery disease in the femoropopliteal vessel segment. The prospective, multi-center, head-to-head, corelab adjudicated RCT […]

thaipr.net

25 ต.ค. 65

Invivoscribe files sPMA with the FDA for use of the LeukoStrat CDx FLT3 Mutation Assay to Select Patients with Newly Diagnosed FLT3-ITD Positive AML

Invivoscribe is pleased to announce that they have filed a supplemental Pre-Market Approval (sPMA) submission with the U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) for the use of the LeukoStrat® CDx FLT3 Mutation Assay as the companion diagnostic for Daiichi Sankyo’s investigational drug quizartinib. The assay is used for the identification of […]

thaipr.net

25 ต.ค. 65

AFTER 30 YEARS — NEW GUIDELINES FOR WEIGHT-LOSS SURGERY

Medical Groups Replace Outdated Consensus Statement that  Overly Restricts Access to Modern-Day Weight-Loss Surgery Two of the world’s leading authorities on bariatric and metabolic surgery have issued new evidence-based clinical guidelines that among a slew of recommendations expand patient eligibility for weight-loss surgery and endorse metabolic surgery for patients with type 2 diabetes beginning at a […]

thaipr.net

25 ต.ค. 65

MedAlliance to be Acquired by Cordis

Swiss-based medical technology company MedAlliance has announced it has entered into an agreement with Cordis for an acquisition which includes an initial investment of $35M and upfront closing payment of $200M, regulatory achievement milestones of up to $125M and commercial milestones of up to $775M through 2029 for a total consideration of up to $1.135 […]

thaipr.net

20 ต.ค. 65

U.S. FDA Grants Emergency Use Authorization for Novavax COVID-19 Vaccine, Adjuvanted as a Booster for Adults

Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, today announced that the Novavax COVID-19 Vaccine, Adjuvanted (NVX-CoV2373) has received emergency use authorization (EUA) from the U.S. Food and Drug Administration (FDA) to provide a first booster dose at least six months after completion of primary vaccination […]

thaipr.net

20 ต.ค. 65

CSafe Continues Expansion of Its Temperature-Controlled Shipping Solutions Portfolio with Introduction of Advanced Reusable Pallet Shipper

Loaded with innovation and technology, CSafeAPS provides superior temperature control and the industry’s only in-transit thermal capacity indicator CSafe, the largest provider of a complete range of active and passive temperature-controlled shipping solutions for the pharmaceutical industry, announced today the launch of its new advanced reusable pallet shipper, CSafeAPS. The new CSafeAPS was engineered to provide […]

thaipr.net

19 ต.ค. 65

EXPERTS FROM THE GLOBAL HYGIENE COUNCIL (GHC) CALL FOR INVESTMENT IN HAND HYGIENE TO SAVE LIVES

On Global Handwashing Day, 15 October 2022, the GHC is calling for investment in handwashing education and resources to achieve universal hand hygiene, prevent disease and save lives. Handwashing with soap is one of the most important steps for reducing the spread of infectious diseases. It is substantially less expensive than other public health interventions and has […]

thaipr.net

17 ต.ค. 65
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