Pavmed (NSDQ:PAVM) is in danger of losing its listing on the NASDAQ exchange, according to a report filed with the Securities & Exchange Commission. In August last year, the FDA group reviewing Pavmed’s 510(k) application for its CarpX minimally invasive carpal tunnel release device asked the company to resubmit the application because the group hadn’t reached […]
Pavmed touts FIH CarpX study launch in pursuit of FDA 510(k) resubmission
Pavmed (NSDQ:PAVM) said yesterday that it launched a first-in-human safety study of its CarpX device to support a planned FDA 510(k) resubmission. The CarpX is a percutaneous device designed to allow the operating physician to relieve compression of the median nerve without a surgical incision. The system combines a balloon catheter with bipolar radio-frequency cutting electrodes […]
ConvaTec taps Bitar as CEO | Personnel Moves – March 26, 2019
ConvaTec (LON:CTEC) said today it tapped Karim Bitar as its new CEO, set to take the position on September 30. Prior to joining the U.K.-based medtech company, Bitar served as CEO of agricultural biotech company Genus, holding the corner office position for approximately eight years. Before his time with Genus, Bitar spent 15 years in various […]
Pavmed plans safety study for CarpX following FDA meeting
After a meeting with the FDA, Pavmed (NSDQ:PAVM) said that the agency wants to see more clinical testing for the CarpX device before it can make a decision on whether or not to approve the product. In August last year, the FDA group reviewing Pavmed’s 510(k) application for CarpX requested that the company resubmit the application […]
Pavmed raises $7m in private placement
Pavmed (NSDQ:PAVM) said this week that it inked a deal to sell a senior secured convertible note of $7.8 million to an institutional investor. The note was sold with an issue discount of $725,000, for gross proceeds to Pavmed of $7 million. Maxim Group, which acted as the placement agent for the transaction, received a 6.5% […]
FDA wants Pavmed to re-submit for CarpX carpal tunnel device
The FDA group reviewing the 510(k) application for Pavmed‘s (NSDQ:PAVM) CarpX device wants the company to resubmit the application. The FDA told the company that it had not reached a consensus within the review period set by the agency’s rules. To extend the review process, the FDA recommended that Pavmed resubmit the application. In a […]
Dynatronics taps ex-NinePoint CEO von Jako as chief exec | Personnel Moves – July 11, 2018
Dynatronics said late last month it tapped former NinePoint Medical CEO Christopher von Jako as its new chief executive officer and board member, succeeding Kelvyn Cullimore Jr. who will stay on the company’s board of directors. Prior to joining Dynatronics, von Jako acted as prez & CEO of NinePoint Medical. Before joining Nine Point, von Jako also […]
Pavmed lands $10m from oversubscribed rights offering
Pavmed (NSDQ:PAVM) said today that it expects to reel in $10.4 million in gross proceeds from an oversubscribed rights offering that expired this week. The New York-based company received subscriptions exceeding the number of rights available under the offering, Pavmed said, adding that it anticipates the offering will close on June 12. Get the full story […]
PavMed subsidiary Lucid Dx inks licensing deal with Case Western Univ.
Pavmed (NSDQ:PAVM) subsidiary Lucid Diagnostics said today it finalized a licensing agreement with Case Western Reserve University to commercialize its EsoCheck non-invasive cell sampling device and DNA biomarker test. The New York-based company said that the EsoCheck device has been shown to effectively and accurately detect Barrett’s Esophagus, which is a precursor to the most common […]
Pavmed registers for $20m rights offering
Pavmed (NSDQ:PAVM) said today that it filed a preliminary prospectus with the SEC for an offering of the rights to buy a new unit in exchange for each share of outstanding common stock. The medical device company plans to offer the rights to purchase up to 9 million units at $2.25 apiece on May 21, valuing […]
7 medtech stories we missed this week: April 27, 2018
From DuPuy Synthes’s spinal implant launch to Lumendi’s FDA clearance, here are seven medtech stories we missed this week but thought were still worth mentioning. 1. DePuy Synthes launches spinal implants DePuy Synthes announced in an April 26 press release that it has launched its Proti 360º integrated titanium family of interbody devices that are designed […]
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