Legacy MEDSearch

APRIL 6, 2023

announced that it has received FDA 510(k) clearance for CardioSTAT, an ambulatory, continuous ECG monitoring solution that relies on a wire free, single-use recorder. The FDA clearance opens the door to the world’s largest medical device market. To this day, CardioSTAT has been prescribed to more than 170,000 patients.

Food and Drug Administration 98

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SEPTEMBER 13, 2022

Potrero Medical announced that the FDA granted Breakthrough Device Designation for their AKI Predict machine learning algorithm, for the advanced prediction of acute kidney injury (AKI) associated with intra-abdominal hypertension (IAH) in cardiac post-surgical intensive care patients. About Potrero Medical. Potrero Medical, Inc.

Medical 98

Medical FDA Recruitment Management 98

pharmaphorum

JULY 19, 2022

Face-to-face discussion educates regulators on what matters most to patients, and guides future decision-making. Regulators are increasingly asking drug developers to include the patient voice in submissions, but the best way to go about this is less clear-cut. The rise of patient centricity. “We

Patients 104

Patients FDA Education Consulting 104

pharmaphorum

NOVEMBER 25, 2022

The FDA has issued a complete response letter (CRL) to Spectrum Pharma for poziotinib, its pan HER2 inhibitor for a form of lung cancer, according to South Korea’s Hanmi Pharma, which originally developed the drug. The post FDA rejects Spectrum’s lung cancer drug poziotinib appeared first on.

FDA 98

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Legacy MEDSearch

OCTOBER 4, 2023

Stimdia Medical, a medical device company developing innovative technologies to improve respiratory care, today announced the initiation of its FDA approved pivotal trial to investigate the impact of phrenic nerve stimulation (PNS) on the time to liberate patients from mechanical ventilation.

Medical 52

Medical Patients FDA Recruitment 52

Legacy MEDSearch

OCTOBER 24, 2023

Food and Drug Administration (FDA) for its novel coronary artery bifurcation stenting technology. “The FDA’s Breakthrough Device Designation is a testament to the potential of our technology to address a critical unmet need in interventional cardiology,” said Dr. . Are you hiring?

FDA 52

FDA Food and Drug Administration Recruitment Food 52

Pharmaceutical Technology

SEPTEMBER 23, 2022

The recent FDA approval of Fennec Pharmaceuticals’ drug PEDMARK (sodium thiosulfate injection) marks a significant advance for cancer treatment-associated hearing loss therapies, amidst a bid to improve quality of life for cancer patients. In 2018, the FDA had granted Pedmark a breakthrough orphan drug designation.

FDA 52

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Legacy MEDSearch

SEPTEMBER 27, 2022

Food and Drug Administration (FDA) 510(k) clearance for its CellFX System, expanding the indication for use to include the treatment of sebaceous hyperplasia in patients with Fitzpatrick skin types I-III. See Full Press Release at the Source: Pulse Biosciences Announces FDA 510(k) Clearance for the Treatment of Sebaceous Hyperplasia.

FDA 98

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SEPTEMBER 18, 2023

Food and Drug Administration (FDA) has approved an investigational device exemption (IDE) supplement to permit the expansion of the study of the eShunt System in patients with Normal Pressure Hydrocephalus (NPH) to additional study participants and clinical sites. CereVasc, Inc., Carl Heilman, M.D., and Adel Malek, M.D.,

Food and Drug Administration 52

Food and Drug Administration FDA Patients Recruitment 52

Legacy MEDSearch

JUNE 9, 2023

Food and Drug Administration (FDA) has granted approval for the DETOUR System to treat patients with complex peripheral arterial disease (PAD). At present, patients with long blockages of the superficial femoral artery (SFA) have limited treatment options. million Americans are affected by PAD.

FDA 52

FDA Patients Food and Drug Administration Recruitment 52

Legacy MEDSearch

NOVEMBER 1, 2022

Food & Drug Administration (FDA) for its smaller-diameter CurvaFix® IM Implant indicated for fixation of fractures of the pelvis. The new 7.5mm device is designed to simplify surgery and to provide strong, stable, curved fixation in smaller patients. CurvaFix, Inc., every year. About CurvaFix, Inc. CurvaFix, Inc.

Food and Drug Administration 98

Food and Drug Administration FDA Recruitment Food 98

Legacy MEDSearch

SEPTEMBER 16, 2022

Food and Drug Administration (FDA) has cleared its Tasso+ lancet as a Class II medical device. Healthcare systems and physicians will also be able to use the Tasso+ device with compatible collection tubes to make determinations on blood chemistries for their patients and expand care access. Tasso, Inc., About Tasso.

Medical 97

Medical FDA Food and Drug Administration Recruitment 97

Legacy MEDSearch

DECEMBER 12, 2022

This most recent FDA 510(k) clearance extends the system’s previous FDA clearances and permits the activation of software functionality that connects to the patient’s bedside monitor and openly transmits treatment information to the central nursing station. ” About IRRAS. Press Release by: IRRAS.

FDA 95

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Legacy MEDSearch

OCTOBER 25, 2022

Food and Drug Administration (FDA) granted Breakthrough Device Designation for the Company’s EndoStim System. “We are pleased that the FDA has recognized the therapeutic potential of the EndoStim System as a new treatment in development for drug refractory GERD,” said Eric Goorno, Chief Executive Officer of EndoStim. .

Food and Drug Administration 98

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Legacy MEDSearch

JANUARY 9, 2023

Lydus Medical is pleased to announce that the Vesseal has received FDA clearance 510(k). The Vesseal is designed to mimic the skill set and dexterity needed to deliver quality patient care in microsurgical anastomoses. Legacy MedSearch has more than 35 years of combined experience recruiting in the medical device industry.

Medical 98

Medical FDA Recruitment Distribution 98

Legacy MEDSearch

DECEMBER 19, 2022

Chairman, Dave Ferrera, announced treatment of the first patients in North America with the BossStent® device designed to treat patients with symptomatic cerebral venous diseases. Both the EU and FDA clinical trials will be initiated in Q2 2023 for the purpose of obtaining European and US regulatory approvals respectively in Q1 2024.

Patients 98

Patients Recruitment Physicians Management 98

Legacy MEDSearch

APRIL 7, 2023

Food and Drug Administration (FDA) has granted 510(k) clearance to the Axiom PSR System for use with the company’s Kinos Axiom Total Ankle System. The Axiom PSR metal resection guides sit noticeably better on the bone and offer greater saw control compared to the historically polymer patient-specific instruments.

FDA 52

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Legacy MEDSearch

JANUARY 4, 2023

Food and Drug Administration (FDA) 510(k) clearance of the BiWaze ® Clear System. This new airway clearance system helps patients clear their airways as well as prevent or treat atelectasis by using Oscillating Lung Expansion (OLE) therapy. We are proud to introduce this innovative OLE therapy system.” Are you hiring?

FDA 95

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Legacy MEDSearch

JANUARY 31, 2023

The newly approved Axonics R20 neurostimulator is labeled for a functional life in the body of at least 20 years and reduces how frequently a patient needs to recharge their implanted device to just once every 6 to 10 months for only one hour. This compares to the third-generation’s recharge interval of once a month for one hour.

FDA 98

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Legacy MEDSearch

JANUARY 3, 2023

Burning Rock, a company focused on the application of next generation sequencing (NGS) technology in the field of precision oncology, announced that its OverC Multi-Cancer Detection Blood Test (MCDBT) has been granted Breakthrough Device Designation by the US Food and Drug Administration (FDA), which is the third of its kind globally.

FDA 95

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Legacy MEDSearch

OCTOBER 2, 2023

Food and Drug Administration (FDA) has approved the EMPAVELI Injector (enFuse ® ) for the subcutaneous delivery of EMPAVELI ® (pegcetacoplan), which is commercialized in the United States by Apellis Pharmaceuticals, Inc. “Enable’s purpose is to redefine drug delivery for the benefit of patients.

Food and Drug Administration 52

Food and Drug Administration Food FDA Recruitment 52

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OCTOBER 10, 2023

Hammerdesis allows surgeons to correct hammertoe deformities and degenerative issues in patients by simply affixing a distinctively designed implant on the patient’s toe joint. Dr. David Murphy, DPM FACFAS remarked, “ Hammerdesis provides patients with a more reliable, and a more consistent option to fix hammertoe issues.

Food and Drug Administration 52

Food and Drug Administration FDA Recruitment Marketing 52

Clarify Health

DECEMBER 13, 2022

Less than four percent of Americans participate in clinical studies; 30 percent of patients drop out; and 80 percent of studies do not meet enrollment deadlines. Dr. Rizk provided an example of how we’re getting better at meeting patients where they are. Below are highlights and key takeaways from the panel.

Recruitment 52

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Legacy MEDSearch

JULY 18, 2023

ReddyPort announced today that the US Food and Drug Administration (FDA) granted 510(k) premarket clearance for the ReddyPort elbow device used in non-invasive ventilation (NIV). 1 The ReddyPort elbow also enables patients and clinicians to use the ReddyPort microphone.

FDA 52

FDA Food and Drug Administration Recruitment Patients 52

Legacy MEDSearch

JULY 25, 2023

The US Food and Drug Administration has cleared a Numares Health test, the AXINON® LDL-p Test System, as a new tool physicians can use to measure lipoproteins for patients at risk for cardiovascular disease. Currently, Numares is the only company in the US selling an FDA-cleared NMR test.

FDA 52

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JANUARY 13, 2023

Hip Innovation Technology , LLC (HIT), a medical device company developing innovative orthopaedic device solutions to advance the quality of life and quality of care for patients, is pleased to announce the first U.S. Safety will be assessed through the collection of device-related adverse events and patient quality of life metrics.

FDA 98

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DECEMBER 1, 2022

HemoSonics, LLC , a leading medical device company delivering individualized diagnostic solutions for Patient Blood Management (PBM), announced that it has received 510(k) market clearance from the U.S. Food and Drug Administration (FDA) for the Quantra Hemostasis System with QStat Cartridge. market today.

FDA 95

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Legacy MEDSearch

OCTOBER 3, 2023

Food and Drug Administration (FDA), for its Seraph® 100 Microbind® Affinity Blood Filter (Seraph 100). The Seraph 100 is a patented blood filter containing a biomimetic surface, similar to that found in the human circulatory system that removes pathogens that could otherwise overwhelm a patient; a common source of severe/critical illness.

FDA 52

FDA Food and Drug Administration Recruitment Medical 52

Legacy MEDSearch

NOVEMBER 28, 2022

The BodyTom 64 brings the power of innovative imaging to patients’ bedsides safely and efficiently. BodyTom 64 is designed and manufactured to comply with the FDA Quality System Regulations and ISO 13485:2016 requirements and is in conformance with global regulatory harmonized standards. Press Release by: NeuroLogica. Are you hiring?

FDA 92

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Legacy MEDSearch

FEBRUARY 8, 2023

market with a breakthrough FDA-Class II medical device, TargetCool. This allows providers to combine TargetCool with other needle-based procedures to minimize patient pain, bruising, inflammation and hematoma that may occur post-procedure. Reviews from early-adopters and their patients have been immensely positive. Recens, Inc.

Management 98

Management Medical Marketing FDA 98

Legacy MEDSearch

NOVEMBER 1, 2023

Food and Drug Administration (FDA) has granted Breakthrough Device Designation for Paige Lymph Node 1 , an AI application used to detect breast cancer metastases in lymph node tissue. Paige Lymph Node is the first AI application of its kind to receive Breakthrough Device Designation from the FDA. Klimstra, M.D.,

FDA 52

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Legacy MEDSearch

MARCH 1, 2024

Food and Drug Administration (FDA) for treating coronary in-stent restenosis (ISR) in patients with coronary artery disease. physicians the opportunity to treat their patients with this novel device.” of balloon angioplasty patients and 17.9% of AGENT DCB patients. Are you hiring?

Food and Drug Administration 52

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Legacy MEDSearch

DECEMBER 21, 2022

Food and Drug Administration (FDA) for 510(k) clearance. If FDA clearance is obtained, the ALICE device production line will be extended for Low-Rate Initial Production (LWRIP), which is an important operational stage in developing infrastructure to support serial manufacturing, quality control and shipping.

Manufacturing 98

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Legacy MEDSearch

SEPTEMBER 13, 2023

Food and Drug Administration (FDA) via the 510(k) pathway, with potential clearance expected during the first half of 2024. The Company’s vision is to transform external breathing assistance for over 20 million patients each year that require ventilation and oxygenation via external mechanical ventilation machinery.

FDA 52

FDA Food and Drug Administration Recruitment Medical 52

Legacy MEDSearch

FEBRUARY 6, 2023

Achieved by leveraging multiple modalities working at up to 3 depths of the skin, this approach allows practitioners to customize and deliver precise treatments based on patient needs while creating volume 3 and strengthening skin structure. Patient satisfaction has gone through the roof after receiving these complementary treatments.”

FDA 98

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AUGUST 17, 2022

an innovative surgical technology company dedicated to providing less invasive options for pediatric patients, announced U.S. FDA clearance for expanded indications for use for the Hummingbird® Tympanostomy Tube System (TTS) for office-based pediatric ear tube procedures. This device has been a gamechanger for patients and families.

Medical 96

Medical FDA Recruitment Insurance 96

Legacy MEDSearch

APRIL 11, 2023

Food and Drug Administration (FDA) granted marketing authorization of the MISHA Knee System, an implantable shock absorber (ISA) for the knee. This system fills that void for both surgeons and patients.” For these patients, total knee replacement is a reluctant option, as it is an end-stage treatment for end-stage disease.

Marketing 96

Marketing FDA Food and Drug Administration Specialization 96