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1. FDA clears Medela’s neonatal enteral feeding device
Medela has received 510(k) clearance from the FDA to market its ENFit Low Dose Tip eternal syringes, according to a March 9 press release. The syringes can help deliver accurate doses and reduce misconnection risks. The new syringes add to Medela’s NICU-specific enteral feeding system products that includes syringes, syringe pumps, warmers, feeding tubes and extension sets. The ENFit Low Dose Tip Syringe was also created to improve oral medication accuracy for small volume delivery in neonatal intensive care units.
2. PAVmed closes additional financing
PAVmed announced the closing of $1 million in additional financing in a March 9 press release. The gross proceeds of PAVmed’s private placement totaled $2.5 million after the closing. The private placement had shares from Series A Convertible Preferred Stock and Series A Warrants. The closing was first announcing in February.
3. InVivo Therapeutics enrolls 12th patient into Inspire study
InVivo Therapeutics announced that a new patient has enrolled in its study of probable benefit of the neuro-spinal scaffold for safety and neurologic recovery in subjects with complete thoracic AIS, according to a March 9 press release. The study, called Inspire for short, is being performed at the Keck Hospital of the University of Southern California. The study’s main researcher, Patrick Hsleh, was able to implant the neuro-spinal scaffold about 82 hours after the injury occurred.
4. Abiomed touts its Impella Heart Pump study
Abiomed posted the positive results of its Impella 2.5 heart pump during high-risk percutaneous coronary intervention in a Circulation Research journal, according to a March 9 press release. The study found that the Impella heart pump can reduce the risk of acute kidney injury, even among patients who have pre-existing kidney conditions and low ejection fraction. The researchers found that 5.2% of the patients who had Impella-supported intervention developed acute kidney injury after the procedure, compared to the 27.8% who didn’t use Impella heart pump. Less than 1% of patients using the Impella heart pump needed hemodialysis after the intervention, compared to the 6.1 percent of the patients who didn’t use the Impella.
5. Exact Imaging receives Health Canada approval for ExactVu micro-ultrasound system
Exact Imaging has received approval from Health Canada to sell its ExactVu high-resolution micro-ultrasound system, according to a March 9 press release. The micro-ultrasound system allows urologists to visualize and distinguish suspicious tissues that allows them to early biopsy prostates. It also creates radio frequency data that helps the research teams evaluate and correlate with pathology to understand apoptosis and how cancerous cells work in therapy.
6. Nexstim signs Texas distribution deal
Nexstim announced that it has signed an independent selling representative agreement with Surgical Solutions in the U.S. to represent the Nexstim Brain Mapping NBS System, according to a March 8 press release. Surgical Solutions is familiar with the neurosurgeon community in Texas because of its 30 years of experience promoting neurosurgical technologies.
7. FDA clears Intellijoint Surgical’s anterior hip navigation software
Intellijoint Surgical has announced that is received FDA clearance of its HIP Anterior, according to a March 7 press release. It is a 3D mini-optical navigation solution that has quantifiable intraoperative measurements for cup position, leg length and is offset for orthopedic surgeons who are performing Direct Anterior Approach (DAA) Total Hip Arthroplasty (THA). Intellijoint Surgical is going to showcase the HIP Anterior at AAOS 2017 March 15–18 in San Diego.
Here’s what we missed last week.
The post 7 medtech stores we missed this week: March 10, 2017 appeared first on MassDevice.
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