class II medical device News
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SWORD Health becomes the only digital musculoskeletal care provider with HITRUST®, SOC 2 and FDA certifications
SWORD Health, a leading provider of digital musculoskeletal (MSK) care, today announced SWORD Health’s digital therapy platform and several of its applications have earned Certified status for information security by HITRUST. The company also completed its Service Organization Control (SOC) 2 Type 2 examination with zero exceptions. The independent audit confirmed SWORD Health’s ...
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Acurable receives US FDA clearance for its home sleep apnoea testing device AcuPebble SA100
AcuPebble SA100, a small wearable device that enables automated, remote home testing to detect obstructive sleep apnoea (OSA) in adults, has obtained FDA 510(k) clearance as a Class II medical device in the USA. The device, which received a CE Mark as a Class IIa medical device in 2020, was developed and is commercialised by UK-based medical device company Acurable and builds on more than ten ...
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Novaerus Defend 1050 cleared by FDA as 510(k) Class II Medical Device
Defend 1050 uses patented NanoStrike® technology to damage and inactivate airborne micro-organisms. Dublin, Ireland and Stamford, CT - Novaerus, a WellAir company that delivers clean air solutions to help prevent the spread of infectious outbreaks, announced today that the U.S. Food and Drug Administration (FDA) cleared the Novaerus Defend 1050 (NV 1050) as a 510(k) Class II Medical Device ...
By WellAir
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Digitsole Pro® is FDA Registered Class II - Innovative AI-Based Solution for Clinical Assessment of Mobility Disorders
Digitsole, a leader in the digital health space bringing together digital mobility biomarkers and biomechanical data with clinical expertise, has received Class II medical device registration with the U.S. Food and Drug Administration (FDA) for its Digitsole Pro® smart insoles. Digitsole Pro®, recently launched in the United States, is a solution, developed with, and for ...
By Digitsole
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New IVD System Enables Assay Developers and Clinical Laboratories to Accelerate Molecular Diagnostics Growth
As assay developers and clinical testing laboratories consider next steps for molecular diagnostics post-pandemic, a new in vitro diagnostic (IVD) system from Thermo Fisher Scientific will enable them to expand their assay menus and IVD testing capabilities moving forward. The Applied Biosystems QuantStudio 7 Pro Dx Real-Time PCR System is a compact instrument that easily transitions from ...
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Six Cleveland Area Hotels Become the First Residence Inn by Marriott Properties in Ohio to Feature PURE Allergy Friendly Rooms
Travelers to the Cleveland area can breathe a little easier knowing that six Residence Inn by Marriott hotels in the greater metropolitan region have introduced PUREAllergy Friendly Rooms. These Residence Inn hotels are setting a new standard by launching PURE Rooms, which create an allergy-friendly environment and remove up to 98% of bacteria and viruses. These ...
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Novel Securement Device Making Inroads
AVA Scientific Meeting 2019 highlights key opportunities for improvement in vascular access from process bundles to emerging new products Introduction Acknowledgment of the importance of the vascular access nurse and team were obvious at this year’s Association for Vascular Access (AVA) Annual Scientific meeting. When Ramzy Nasrallah took over as CEO for the Association of Vascular Access ...
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BlueWind Initiates U.S. Enrollment in Clinical Trial of the RENOVA iStim to Treat Overactive Bladder
BlueWind Medical announced today that enrollment has commenced at U. S. sites in the Pivotal Clinical Trial of the RENOVA iStim™ implantable tibial neuromodulation System (RENOVA) for the treatment of Overactive Bladder (OAB) following conditional Investigative Device Exemption (IDE) approval by the U.S. Food and Drug Administration (FDA). There are approximately 40 million adults in the ...
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Case Western Reserve University, in Collaboration with NDI Medical, SPR Therapeutics and Valtronic Technologies, Receives $3 Million from Ohio Third Frontier Commission
Case Western Reserve University, in collaboration with NDI Medical LLC, SPR™ Therapeutics, and Valtronic, has been awarded a $3 million grant from the Ohio Third Frontier Commission to commercialize a neurostimulation technology platform designed to treat multiple clinical indications with significant unmet needs, including pain and muscle paralysis. The Ohio Third Frontier Innovation ...
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Howard Leonhardt and Alex Richardson of Second Heart Assist discuss regenerating hearts and novel medical devices
During their recent visit to Victoria BC for lab testing services, Second Heart Assist Chairman and CEO, Howard Leonhardt (HL), and VP of Engineering & Product Development, Alex Richardson (AR), spoke with ViVitro Lab and Interim General Manager, Rob Fraser (RF), about their work at Second Heart Assist, and Leonhardt Ventures. RF: You both have a long history with medical devices. Please ...
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