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Home » Topics » Regulatory » 510(k)

510(k)
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Spintech’s MRI enhancement technology gets FDA nod

Aug. 10, 2021
By Meg Bryant
The FDA has given the green light to Spintech Inc. for its STAGE (strategically acquired gradient echo) magnetic resonance imaging device. The post-processing software platform allows MRI technicians to capture higher-quality brain images in significantly less time than standard approaches.
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Laptop displaying FDA logo

FDA says PMA first cycle major deficiency rate approaching 21st century high

Aug. 5, 2021
By Mark McCarty
The FDA’s quarterly report on device user fee performance goals encodes a number of metrics, such as the rate at which PMA originals are cited for a major deficiency on the first review cycle. For premarket approval applications (PMAs) filed in fiscal year 2021 to date, the major deficiency rate on the first cycle is 86%, which would be tied for the fifth highest rate in two decades if that rate holds throughout the balance of the fiscal year.
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Photo of Linq II device

FDA greenlights two Medtronic AI algorithms for cardiac monitoring

July 28, 2021
By Meg Bryant
Medtronic plc got a thumbs up from the FDA for two Accurhythm algorithms to detect atrial fibrillation and asystole in patients who have heart rhythm abnormalities. The new artificial intelligence (AI)-based algorithms are designed for use on the company’s Linq II insertable cardiac monitor (ICM). Dublin-based Medtronic said the Accurhythm AI algorithms will be available on its Carelink Network later this year for use with all implanted Linq II devices in the U.S.
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Omniscient co-founders and CEO with Quicktome software displayed behind them

FDA clears Omniscient Neurotechnology’s Quicktome brain mapping platform for neurosurgery

July 22, 2021
By Tamra Sami
PERTH, Australia – The FDA gave the thumbs up to Omniscient Neurotechnology Ltd.’s Quicktome, the first brain connectomics planning software that provides neurosurgeons with a digital brain mapping platform to visualize and understand a patient's brain networks before performing brain surgery. By visualizing networks that are responsible for complex functions such as language, movement, and cognition, Quicktome assists neurosurgeons in making more informed decisions and reduces surgical uncertainty.
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3D illustration of shoulder with Inspace implant

FDA greenlights Stryker’s balloon implant for shoulder repairs

July 16, 2021
By Meg Bryant
Stryker Corp. has won the FDA’s nod for an implantable balloon spacer to aid in the healing of torn rotator cuffs. The de novo clearance of the Inspace subacromial tissue spacer system comes more than a decade after the biodegradable shoulder repair implant first debuted in European markets. The minimally invasive Inspace device is intended for arthroscopy treatment of massive irreparable rotator cuff tears (MIRCTs).
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Pivot breath sensor and app on phone

Carrot tweaks labeling for smoking cessation breathalyzer

July 12, 2021
By Ana Mulero
Looking to increase adoption among more tobacco users, Carrot Inc. expanded the indications for use of its smoking cessation breathalyzer with a new FDA 510(k) clearance to include the claims related to a recent study in the labeling and promotion of the sensor. The clinical trial demonstrated the Bluetooth-enabled sensor’s ability to increase a person’s motivation to quit.
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Arctic Front in heart illustration

Medtronic expands FDA approval for cryoablation device

June 22, 2021
By Ana Mulero
Medtronic plc won expanded FDA 510(k) approval for its Arctic Front family of cardiac cryoablation catheters for alternative treatment of recurrent symptomatic paroxysmal atrial fibrillation (AF) as an alternative to the current standard first-line treatment, antiarrhythmic drug (AAD) therapy. The Arctic Front family of catheters are the first catheter ablation devices in the U.S. approved to help physicians improve AF patient outcomes before drug failure. They have also been proven to shorten the time to diagnosis, according to Dublin-based Medtronic.
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Couple at home using Invu device and mobile app

Nuvo gets FDA nod for remote monitoring of uterine activity

June 18, 2021
By Meg Bryant
It’s not unusual for women to have some uterine contractions during pregnancy. Many of these go unnoticed, but others can be strong and feel like labor. Distinguishing between normal contractions and those that are not can help ensure women at risk of preterm labor get the extra medical care they need. To that end, Tel Aviv-based Nuvo Group Ltd. has launched an FDA-cleared uterine activity (UA) module on its Invu remote monitoring platform.
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Neurescue device image

Neurescue’s aortic occlusion device gets FDA nod for hemorrhage and IDE for cardiac arrest

June 10, 2021
By Annette Boyle
The FDA granted Neurescue a "two-fer" on its intelligent balloon catheter for aortic occlusion with 510(k) clearance for emergency control of hemorrhage and investigational device exemption for use in cardiac arrest. By inflating a soft balloon at diaphragm level, the device dramatically increases perfusion to the heart, brain and lungs within a minute of deployment via the femoral artery.
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Knee pain illustration

FDA clearance gives Cymedica a leg up on osteoarthritis knee pain

June 9, 2021
By Annette Boyle
Cymedica Orthopedics Inc. received FDA clearance for its Intellihab system to reduce pain associated with osteoarthritis in the knee. The system uses neuromuscular electrical stimulation to strengthen muscles supporting the knee without requiring typical exercises such as squats that could increase pain and further degrade the joint. Intellihab includes a knee brace that emits the pulses and a smartphone app patients use to track and manage the therapy.
Read More
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