Lucid Diagnostics has received the CE mark for its EsoCheck esophageal cell collection device, its parent company announced today. EsoCheck is an FDA-cleared, swallowable balloon capsule catheter that enables a clinician to sample surface cells from the esophagus in a less than five-minute, non-invasive office procedure. Lucid touts EsoCheck as the only such device capable of […]
Pavmed
PAVmed wins CE mark for carpal tunnel device
PAVmed (NSDQ: PAVM) today announced that it has received the CE mark for its CarpX minimally invasive carpal tunnel device. EU-based Notified Body TÜV Rhineland LGA Products GMBH issued CE certificate, effective May 24, 2021, the company noted. CarpX may now be marketed in CE Mark European countries, which include the European Economic Area (the EU, […]
DTW Podcast: Geoff Martha updates Medtronic’s new course; AJAX CEO Duke Rohlen is funding innovation differently
Less than a year into his role as CEO, Geoff Martha and the Medtronic leadership has overseen a significant reorganization of medtech’s largest player. In our closing keynote conversation, Martha says the company is clearing a minor COVID-19 bump and sees open road for the company to continue to grab share from competitors. Martha details […]
PavMed to spin off subsidiary Lucid Diagnostics
Pavmed (NSDQ:PAVM) announced today that its majority-owned subsidiary Lucid Diagnostics will spin off into a separate public company. In a news release, Pavmed said Lucid Diagnostics intends to spin off if favorable market conditions continue to hold, whether it be through an initial public offering (IPO) or a business combination with a healthcare special purpose acquisition corporation. […]
Pavmed closes $12.4m offering
Pavmed (NSDQ:PAVM) announced last week that it closed a registered direct offering of common stock shares worth $12.4 million. New York-based Pavmed’s previously announced offering included 6 million shares of common stock at a price of $2.24 per share, priced at-the-market under Nasdaq rules, according to a news release. The company estimates that the net proceeds […]
Pavmed raises $7.8M
Pavmed (NSDQ:PAVM) filed an SEC Form D to confirm the sale of $7.75 million in an offering of debt and options/warrants to purchase other securities. In selling the $7.75 million, New York-based Pavmed reached its total offering amount in the new notice, which made its first sale on Aug. 5. Pavmed did not intend for the […]
Pavmed completes $4.1m offering
Pavmed (NSDQ:PAVM) filed an SEC Form D to confirm the sale of more than $4 million in debt, options, warrants and other rights to acquire securities. The medical device company completed its total offering of approximately $4.1 million, having made its first sale on April 30, according to the filing. It took just one investor to […]
Pavmed to resubmit carpal tunnel device 510(k) application
Pavmed (NSDQ:PAVM) said today that it has reapplied for FDA 510(k) clearance for its CarpX device designed to treat carpal tunnel syndrome. In August 2018, the FDA group reviewing the application for CarpX requested that the company resubmit the application because the group hadn’t reached a consensus within the designated review period. The resubmission incorporates data […]
Pavmed’s Lucid Diagnostics enters clinical trial with U of Penn
Pavmed (NSDQ:PAVM) announced today that its majority-owned subsidiary Lucid Diagnostics entered into a clinical trial research agreement with the University of Pennsylvania to observe its EsoCheck esophageal cell collection device. EsoCheck with “collect & protect technology” is designed to offer a less invasive, more efficient and cost-effective alternative to endoscopic biopsies when managing patients with eosinophilic […]
Pavmed gains FDA breakthrough nod for esophageal pre-cancer test
Pavmed (NSDQ:PAVM) recently announced that its Lucid Diagnostics subsidiary has received FDA breakthrough device designation for its EsoGuard esophageal DNA test. The test uses esophageal samples collected using Lucid’s 510(k)-cleared EsoCheck cell collection device from certain patients at elevated risk for esophageal dysplasia due to chronic gastroesophageal reflux disease (GERD). EsoGuard and EsoCheck are designed to […]
Pavmed back in NASDAQ compliance
Pavmed (NSDQ:PAVM) said today that it has received formal notice from NASDAQ that it has returned to compliance with the stock exchange’s listing rule after 10 consecutive days with a closing bid price of at least $1 per share. NASDAQ warned the company in November that it was in danger of delisting due to poor […]
