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EP Lab Digest
08/08/2024
ATLANTA, Aug. 7, 2024 / -- Huxley Medical, a developer of technologies that streamline cardiopulmonary care, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its groundbreaking, chest-worn, sleep apnea diagnostic patch, SANSA.
With this clearance, Huxley Medical can move forward to market its device.
EP Lab Digest
08/08/2024
Cadrenal Therapeutics, Inc., press release
EP Lab Digest
08/08/2024
Eko Health outfits LSU Athletic Sports Medicine team with CORE 500 digital stethoscopes and AI algorithms for the enhanced detection of cardiac conditions during athlete physical exams
EP Lab Digest
08/08/2024
• Company’s proprietary system used in study for patients with atrial fibrillation
• Cardiac Surgery System enrolled in the FDA’s Total Product Life Cycle (TPLC) Advisory Program (TAP)*
EP Lab Digest
08/08/2024
The annual meeting is designed to elevate patient care in the Asia-Pacific region
EP Lab Digest
08/08/2024
New Feature Elevates Hospital Inventory Control with Market-Exclusive Inter-Hospital Value Transfers
Oncology
08/08/2024
The US Food and Drug Administration approved novel immunotherapy denileukin diftitox-cxdl for the treatment of patients with relapsed/refractory cutaneous T-cell lymphoma after at least 1 prior systemic therapy.
Neurology
08/08/2024
Compared with moderate-dose therapy, high-dose statin therapy in patients with mild ischemic stroke did not decrease the risk of stroke recurrence and was associated with an increased risk of intracranial hemorrhage over 12 months.
Psych Congress NP Institute
08/08/2024
According to Amber Hoberg, MSN, APRN, PMHNP-BC, when matching antipsychotic interventions to clinical factors for a patient, what is the most important consideration?
Psych Congress Network
08/08/2024
Nishi Bhopal, MD, clarifies 5 common misconceptions about sleep medicine for mental health care practice.
Wound Care
08/08/2024
Avita enters into an exclusive 5-year development and distribution agreement with Regenity Biosciences for a unique collagen-based dermal matrix. Upon 510(k) clearance expected Q424, Avita will make an initial $2.0MM payment followed by additional payments to support manufacturing.
Wound Care
08/08/2024
MiMedx announces the launch of its first xenograft product, HELIOGEN, a particulate fibrillar bovine collagen matrix for addressing complex wounds primarily in the surgical setting.
Wound Care
08/08/2024
Polaroid Therapeutics announced its partnership with Speciality Fibres and Materials Ltd to test a novel wound dressing that prevents infection and aids healing. The trials aim to create a breakthrough in advanced wound care, particularly for cavity wounds.
Wound Care
08/08/2024
MiMedx management noted that the increase in revenue was partially offset by commercial challenges due to sales of artificially high-priced skin substitute products by competitors, the uncertainty of Medicare reimbursements and sales team turnover. Q224 MDXG Earning Release
Wound Care
08/08/2024
Results of a 196-patient RCT comparing the efficacy of ExcharEx for debridement of VLUs vs placebo (GV) and nonsurgical SoC (NSSOC) showed a significantly higher incidence of complete debridement at 63% compared to GV (30.2%) and NSSOC (13%), without significant safety issues. The Lancet
Wound Care
08/08/2024
AOTI announces US FDA 510(k) Clearance for an extension of the indications for their NEXATM NPWT System. The amended indications, "for use in acute, extended and home care settings…," will allow the device to be marketed to additional care sites.
Wound Care
08/08/2024
Integra announced plans to restart the manufacture of PriMatrix and SurgiMend at its new manufacturing facility in Braintree, Massachusetts in H126. IART also noted it expects Integra Skin sales to be at normalized run rates during Q424. IART Q2424 Earnings Transcript
Cath Lab Digest, CardioVascular, Journal of Invasive Cardiology
08/08/2024
A cardiovascular health construct based on the American Heart Association’s Life’s Essential 8 but enhanced with a ninth psychological health metric strongly predicts all-cause and cardiovascular mortality, according to a new study at Columbia University’s Mailman School of Public Health.
Wound Care
08/08/2024
In H224, Convatec expects to further grow sales of InnovaMatrix by pursuing other indications and by starting the launch of InnovaMatrix outside of the US. In addition, RCT’s are to be initiated for VLUs and DFUs in Q324. CTEC H124 Earnings Release
Pharmacy Learning Network
08/08/2024
SoloVital.com, based in Chula Vista, California, is recalling all lots of the dietary supplement Umary Acido Hialuronico, Suplemento Alimenticio.