Tasso+™ Device Earns FDA 510(k) Class II Medical Device Clearance

Tasso, Inc., the leading provider of convenient, clinical-grade blood collection solutions, announced that the U.S. Food and Drug Administration (FDA) has cleared its Tasso+™ lancet as a Class II medical device. The clearance allows the company to market and sell the device to more pharmaceutical companies, healthcare organizations, and academic institutions across the country, expanding…

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MedWand Solutions Receives FDA 510k Clearance

MedWand Solutions, Inc. is pleased to announce that the company’s groundbreaking MedWand device and VirtualCare ecosystem is commercially available to enable clinical exams with its comprehensive care solutions. Poised to transform the current capabilities of telemedicine, MedWand is offering various kits including: the MedWand Evaluation Kit, the MedWand Mobile Clinic, and the MedWand Remote Clinic. By facilitating a more…

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Cognito Therapeutics Announces Proprietary Gamma Sensory Stimulation for 6-Months Reduces White Matter Atrophy in Alzheimer’s Disease Patients

Cognito Therapeutics, announced that its proprietary gamma sensory stimulation at 40Hz over a 6-month period reduced white matter atrophy in the brain for patients with Alzheimer’s Disease, according to new data presented at the Alzheimer’s Association International Conference 2022. Alzheimer’s Disease (AD) is the most common form of dementia. Although white matter atrophy is observed…

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Alio Remote Monitoring Technology Receives First FDA 510(k) Clearance

Alio Inc., announced it received FDA 510(k) clearance for its remote monitoring system intended for use by healthcare professionals to intermittently collect physiological data in home use settings. Collected physiological data includes skin temperature, auscultation sound data and heart rate. Alio technology provides real-time, 24/7, noninvasive remote patient monitoring. By sharing clinical data, Alio makes…

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Nipro introduces SURDIAL™ DX Hemodialysis System to U.S. Market

Nipro Medical Corporation (Nipro), a leading manufacturer and supplier of renal, vascular, and medical-surgical products, announced the commercial launch of SURDIAL™ DX Hemodialysis System to the U.S. SURDIAL™ DX is a state-of-the-art hemodialysis system designed to create an optimal dialysis treatment experience for patients and clinicians. Manufactured in Japan, it draws from over 35 years of…

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Fresenius Kabi Receives FDA 510(k) Clearance for Wireless Agilia® Connect Infusion System with Vigilant® Software Suite-Vigilant® Master Med Technology

Fresenius Kabi, a global health care company that specializes in medicines and technologies for infusion, transfusion and clinical nutrition, announced it has received 510(k) regulatory clearance from the U.S. Food and Drug Administration (FDA) for its wireless Agilia® Connect Infusion System which includes the Agilia® Volumetric Pump and the Agilia® Syringe Pump with Vigilant® Software Suite-Vigilant® Master Med technology. The Agilia Connect…

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Valencia Technologies Gains FDA Approval of eCoin® Therapy to Treat Urinary Urge Incontinence

Valencia Technologies Corporation, a privately held company, announced that the U.S. Food and Drug Administration (FDA) has granted premarket approval (PMA) of its eCoin® leadless tibial neurostimulator for the treatment of urinary urge incontinence (UUI), which affects over 60% of patients who suffer from Overactive Bladder (OAB). FDA approval was supported by the efficacy and favorable…

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Medtronic to Acquire Intersect ENT for $1.1B

Medtronic plc (NYSE:MDT), the global leader in medical technology, today announced that it has entered into a definitive agreement with Intersect ENT (NASDAQ: XENT), a global ear, nose, and throat (ENT) medical technology leader dedicated to transforming patient care, in which Medtronic will acquire all outstanding shares of Intersect ENT for $28.25 per share in an all-cash…

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Dexcom Wins FDA Nod for Real-time APIs, Allowing Third-party Developers Access to CGM Data

Dexcom’s Partner Web Application Programming Interfaces (APIs) were cleared by the FDA, allowing approved third-party developers to connect to the continuous glucose monitoring data of Dexcom users. Developers can integrate CGM data with their applications, diabetes management systems or devices through the new APIs, according to Thursday’s announcement. Diabetes management companies like Teladoc Health’s Livongo for Diabetes and…

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Cognoa Receives FDA Marketing Authorization for First-of-its-kind Autism Diagnosis Aid

Cognoa, a pediatric behavioral health company developing diagnostic and therapeutic solutions for children living with behavioral health conditions, today announced that the U.S. Food and Drug Administration (FDA) has granted the company’s De Novo classification request for its autism diagnosis aid. The AI-based device is the first FDA-authorized diagnosis aid designed to help physicians to…

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