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Home » breakthrough device designation

Articles Tagged with ''breakthrough device designation''

Bladder cancer illustration

Anchordx wins FDA’s breakthrough device designation for bladder cancer test

Aug. 16, 2021
By David Ho and Doris Yu
The FDA has granted Anchordx Medical Co. Ltd.’s Urifind, an early detection test for bladder cancer, a breakthrough device designation (BTD). This marks the first BTD given to a liquid biopsy test for bladder cancer detection in China, putting it in good stead as it gears up for an IPO.
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X-Ray showing scoliosis

FDA grants breakthrough status to Auctus for scoliosis treatment system

Aug. 11, 2021
By Annette Boyle
Auctus Surgical Inc. took another step toward straightening out one of the most vexing problems in pediatric scoliosis with the announcement of FDA breakthrough device designation for its vertebral tethering system. The system offers a non-surgical option to correct spinal curvature without use of fusion or braces and its dynamic magnetic technology enables adjustment as a child grows, avoiding the overcorrection that plagues the only other tethering system currently available.
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Mobile phone displaying Swing's app

Swing Therapeutics gets breakthrough nod for fibromyalgia digital therapeutic

Aug. 11, 2021
By Meg Bryant
The digital therapeutics market has seen an explosion of innovative products and interested investors. Regulators, too, have acknowledged their potential to improve outcomes in patients with chronic or debilitating conditions – often at lower cost and with less side effects than traditional drug therapies. To that end, the FDA has granted breakthrough device designation to Swing Therapeutics Inc. for its prescription digital therapeutic for the management of fibromyalgia.
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Photo of man wearing Phoenix earbuds

Evren Technologies snags FDA breakthrough nod for PTSD therapy

July 30, 2021
By Meg Bryant
Post-traumatic stress disorder (PTSD) affects about 8 million Americans a year, disrupting lives with nightmares, memory loss, feelings of isolation and other negative effects. Treatment typically involves psychotherapy, but many patients do not find relief. To that end, the FDA has granted breakthrough device designation to Evren Technologies Inc. for its noninvasive Phoenix earbud device for treating PTSD.
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Clinician accessing Biovitalshf dashboard on computer

FDA grants breakthrough status to Biofourmis’ digital therapy for heart failure

July 29, 2021
By Meg Bryant
Biofourmis Inc. won a breakthrough devices nod from the FDA for its Biovitalshf solution, a digital therapeutic for patients with heart failure with reduced ejection fraction (HFrEF). The company, which is pursuing the de novo pathway for the therapy, plans to launch a pivotal trial next month. Biovitalshf is intended to augment guideline-directed use of heart failure medications to manage patients in combination with traditional pharmacotherapy. The software application integrates physiological monitoring, symptoms and signs reporting, patient engagement, medication management and communications to provide clinicians with personalized and specific recommendations about their medication.
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Transaeris system

Synapse’s diaphragm pacing system nabs FDA breakthrough status

July 23, 2021
By Meg Bryant
Synapse Biomedical Inc. has won breakthrough device designation from the FDA for its Transaeris system, a diaphragm pacing system (DPS) for use in weaning patients off mechanical ventilation. The minimally invasive device has been in use during the COVID-19 pandemic under an emergency use authorization to prevent ventilator-induced diaphragm dysfunction – a condition that occurs following mechanical ventilation, which leaves the diaphragm weak from disuse.
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Royal Philips building in Amsterdam

Philips’ laser-assisted IVC filter removal device achieves FDA breakthrough designation

July 21, 2021
By Ana Mulero
The FDA granted breakthrough device designation to Royal Philips NV for its laser-assisted inferior vena cava (IVC) filter removal device. The Amsterdam-based company designed the device to ablate tissue for removing an IVC filter when previous methods of removal have already failed.
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Woman sits in chair wearing Quell device below knee, using smartphone app

Neurometrix’s wearable Quell device wins FDA breakthrough designation

July 20, 2021
By Meg Bryant
Fibromyalgia is an often debilitating condition, characterized by chronic pain throughout the body that can leave patients fatigued, depressed and unable to perform even the simplest of activities. While a handful of drugs have been approved to treat this autoimmune disorder, they can have unpleasant side effects and do not benefit all patients. To that end, the FDA has granted a breakthrough device designation to Neurometrix Inc.’s Quell wearable neurostimulation device for treating the symptoms of fibromyalgia in adults.
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Illustration of ChEVAS in abdominal aortic aneurysm

Endologix gets breakthrough nod for endovascular abdominal aneurysm sealing tool

July 19, 2021
By Meg Bryant
The FDA has granted breakthrough device designation to Endologix LLC for its Chimney Endovascular Aneurysm Sealing (ChEVAS) system. The device, which is intended for use in treating aortic aneurysms, is currently being evaluated in a multicenter pivotal study. The ChEVAS system is an endovascular abdominal aortic aneurysm (AAA) therapy designed to combine the Nellix 3.5 endograft with parallel visceral chimney stents to enable treatment of patients with juxtarenal, pararenal and suprarenal AAA.
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Illustration of spine before and after Miscoli

VBT device for treating adolescent scoliosis awarded breakthrough device designation

July 13, 2021
By David Godkin
TORONTO – Spino Modulation Inc., a subsidiary of Montreal-based med-tech company Spinologics Inc., has received breakthrough device designation for a vertebral body tethering (VBT) device to treat adolescent idiopathic scoliosis, one of three types of scoliosis that cause the spine to develop an abnormal curve.
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